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1. 5 3 2 Scroll if applicable Blood and Recurrence Biopsy Submission All scrolls Gf applicable blood specimens and recurrence biopsies are to be submitted Monday Through Thursday NO Saturday delivery to NCI CCG Biospecimen Core Resource Nationwide Children s Hospital Attn Kristen Leraas 700 Children s Dr WA1340 Columbus OH 43205 Tel 614 355 3589 5 4 Inadequate Submissions 5 4 1 Response Genetics If the blocks or slides submitted to Response Genetics for ALK EGFR testing are inadequate or fail to yield a result Response Genetics will contact the site requesting an additional submission 5 4 2 Biospecimen Core Resource If the remaining tissue from RG or the scrolls submitted by sites are found to be inadequate for genomic analysis the BCR will submit that data to the Data Center The Data Center will then post this information via RAVE see Appendix I after which the site may choose to submit additional tissue for genomic testing If a site would like to submit additional specimens to BCR for genomic studies please contact the BCR at 614 355 3589 6 0 CLINICAL DATA REQUIREMENTS 6 1 Follow up e Patients that have a block or slides scrolls and blood specimens submitted and deemed adequate for research genomics but are NOT going on either AO81105 or E4512 will be followed on A151216 every 6 months for 5 years Patients that meet one or more of the following criteria will not be followed on A151216 e2. bas been added to the end of the fourth bullet underneath the For all patients section Inthe 7 bullet of the same section we now state that patients who have had local genotyping are eligible regardless of the local result The previous eligibility criteria did not allow patients who had wild type EGFR and ALK to enroll Additionally the criteria making patients with a KRAS mutation ineligible has been removed The criteria No interstitial fibrosis or lung disease has been removed from this section Section 3 2 Patient Registration Eligibility Criteria The title of this section has been updated to include the word Registration The 1 bullet point has clarified the eligible histologic subtypes The last bullet point has been added to address the timing of registration for patients Section 4 0 Patient Pre registration and Registration The statement Those patients that have already had surgery will complete the registration process at the same time as pre registration has been bolded This was done to emphasize that pre registration and registration to A151216 should occur simultaneously in patients registered post operatively The last sentence has been added to clarify that patients may be receiving adjuvant therapy at the time of registration to A151216 Section 4 5 Patient Registration Procedures The statement Patients pre registered post operatively will complete the registration p
3. Version Date 02 09 15 18 Update 01 A151216 APPENDIX I For laboratory use ALCHEMIST laboratory flow diagram Eligible patient pre registers m registers to A151216 All sites send blood specimen 1 A OR N to BCR BLOCKS Site sends tissue block to SLIDES SCROLLS Site sends Response Genetics RG for EGFR ALK slides to RG scrolls to BCR genotyping Block sit AND Nn RG receives specimen is specimen adequate for EGFR Site sends Site sends ALK genotyping unstained scrolls slides to RG AND one No a H amp E slide to BCR RG to query site for an additional specimen eee RG sends to BCR eae ANY remaining material RG receives 8 cond gt hi Genotyping results if possible specimen p 40x H amp E M S s BCR receives specimen is RG reports RG completes specimen adequate for research results RAVE form genomics positive N negative or F Tes ae a BCR completes RAVE form BCR completes one vue note site permitted to submit RAVE form pusiiess ays additional tissue if available Alliance terminates follow up All specimens sent or received must be logged into BioMs Sites will have view access to these results amp adequacy CRFs Alliance Data Center will review specimen adequacy results at least quarterly to identify problems and implement improvements Results will be returned to CRA and ordering clinician using contact information from requisition Sites are p
4. A151216 site Pre registration and Registration e CTSU IRB Certification e CTSU IRB Regulatory Approval Transmittal Sheet Version Date 02 09 15 8 Update 01 A151216 4 2 OPEN Registration System Access Requirements e All participating institutions Alliance and CTSU will use the OPEN Oncology Patient Enrollment Network to enroll patients to this study OPEN is a web based registration system for patient enrollments onto NCI sponsored cooperative group clinical trials OPEN provides the ability to enroll patients 24 hours a day 7 days a week e To enroll a patient within OPEN institution staff must have 1 A valid and active CTEP IAM account This is the same user ID and password used for CTSU s website for more information see https www ctsu org public CTEP AM_Factsheet pdf 2 A registrar role within either the CTSU roster and or the Cooperative Group roster e If you are an Alliance member enrollment of patients on CALGB coordinated protocols requires a Registrar role in the CALGB roster Assignment of the registrar role are managed through the Alliance Central Office e If you are a non Alliance member enrollment of patients on Alliance coordinated protocols requires a Registrar role in the CTSU roster Institution staff may manage CTSU roster roles via the Regulatory Support System RSS on the CTSU Web site Although assignment of the Registrar role may be managed in this manner pleas
5. NSCLC using widely accepted genomic assays EGFR mutation testing and ALK FISH in a centralized CLIA certified laboratory using resources from NCI There are several advantages to this approach First centralized assays will be used for EGFR and ALK genotype analyses minimizing technical inconsistencies Second the access to molecular testing will not be constrained by physician preferences or insurance approval Third additional genomic tests can be added to this platform over time to study other genotype defined subtypes of NSCLC Fourth this trial will present an opportunity to characterize the natural history of NSCLC carrying less common genotypes other than EGFR mutant and ALK rearranged NSCLC through coordination with research genomics performed at Center for Cancer Genomics CCG Finally working closely with CCG the ALCHEMIST trial will facilitate large scale unbiased comprehensive molecular using genome exome and transcriptome analyses to identify additional potentially targetable gene alterations Facilitating the Development of Next generation Genomics Next generation genomics is increasingly being adopted into research and clinical efforts around the country such that the limitations of DNA sequencing are slowly being discovered To move beyond DNA sequencing and study gene expression and epigenetics a rigorous central effort is needed Already a third generation of genomic technologies is in development that allows RNA sequ
6. Patients that are pre registered only This will be a very small percentage of patients who are registered pre operatively and are found at surgery not to be eligible to participate on A151216 e Patients that are EGFR or ALK positive and are enrolled on either A081105 or E4512 They will be followed on the adjuvant trial 7 0 STATISTICAL CONSIDERATIONS This is a central biomarker screening trial that 1s designed to screen resected lung cancers for targetable genomic alterations 7 1 Sample Size It is estimated that up to 8000 patients may need to be genotyped in order to fully accrue to the EGFR estimated prevalence 15 and ALK estimated prevalence 5 studies Fewer patients Version Date 02 09 15 13 Update 01 A151216 may need to be screened depending upon adoption of pre screening strategies such as clinical selection or local genotyping 7 2 Baseline Clinical Information At time of registration patients will assist the CRA in completing the on study forms to report characteristics that may be associated with the planned genomic analysis including the following data e Age gender racial background e Personal history of cancer and other pulmonary disorders e Family cancer history including family smoking history History of occupational and environmental exposures including prior radiation e Smoking history including second hand smoke exposure 7 3 Clinical Follow up Plan Given the large number of subjects
7. been removed e Under the Patient Registration Eligibility Criteria the reference to the timeframes being added to Section 3 0 has been added e The schema diagram has been arranged to make it clear that post op patients should be registered at the same time as pre registration e The collection of blood has been added to the schema Blood should be obtained following pre registration up to 30 days following registration Section 1 6 Central Clinical Genotyping The first sentence has been updated to state including those with local genotyping results to reflect the change in eligibility which now allows patients with a locally negative result to be registered to A151216 Section 3 1 Patient Pre registration Eligibility Criteria This entire section has been reorganized for better understanding Changes include A For pre surgical patients subsection has been added which includes the pre surgical patient criteria A For post surgical patients subsection has been added which includes the post surgical patient criteria A For all patients subsection has been created which lists the criteria that all patients need to meet Changes in this section include In the neoadjuvant therapy criteria second bullet the words for this lung cancer have been included The sentence A secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216
8. should be registered within specific timeframes based on adjuvant chemo see Section 3 2 Schema Obtain blood e at any time one el reg to 30 days V post reg Surgery FFPE block collected Patients are not Ineligible T registered and will Em Final eligibility review not be followed Eligible Register FFPE tissue submitted for EGFR and ALK genotyping at RGI AND research genomics at BCR Post op patients will pre register and register at the same time Group A Central EGFR or Group B Central EGFR or Group C Central EGFR and ALK ALK complete AND ALK testing complete BUT testing incomplete and incomplete enrolling in either not enrolled on adjuvant trial FFPE tissue submitted for research A081105 or E4512 AND FFPE tissue submitted genomics for research genomics No A151216 follow up use A081105 E4512 follow up plan Yo P If recurrence send tissue from biopsy to BCR Follow up on A151216 End follow up wh every 6 months for 5 years na lovow up when notified by Alliance Data Center Version Date 02 09 15 3 Update 01 A151216 TABLE OF CONTENTS SECTION PAGE UP Peed 0 1 ex 08 HU el Cc emer ere eteicnes trem erie oreo west E re nT Sr Oe enter Re EER Se ore TO 5 1 1 Selecting Therapies Based Upon Lung Cancer Genotype sssssussssussusunnununnunnnnunnununnunnnnnnnnnnnnne 5 1 2 Adjuvant Targeted THErapies sciicccisesenscavscstinitarendescatnscoatenraasavedovaniinirininuiatiadeien 5 1
9. the site Prior to distribution of the block the site should cut stain and review one section of the study block to confirm that it is representative of the clinical diagnosis document tumor cellularity by histological review This H E stained slide should be submitted with the block to Response Genetics Response Genetics will then forward the remaining block to the BCR for genomic research OR Clinical Tissue Block The site pathologist should identify one block of primary tumor tissue from the case that is representative of the histological diagnosis contains at least 1 cm of tissue on the block face and document tumor cellularity by histological review This H E slide should be submitted with the block to Response Genetics Response Genetics will then forward the block to the BCR for genomic research Note that if the block is required by the site at some future date for clinical patient management the block will be returned to the site within upon a written request if physically possible but this cannot be guaranteed OR Tissue Slides and Tissue Scrolls Tissue Slides The site pathologist should identify one block of primary tumor tissue from the case that is representative of the histological diagnosis and document tumor cellularity by histological review A total of five 5 10 micron sections plus three 3 5 micron sections should be cut and mounted on positively charged glass slides and shipped to Response Genetics Tiss
10. 3 Managing Resected lung Adenocarcinoma as a Genomically Diverse Disease 5 1 4 Facilitating the Development of Next generation GENOMICS ssssssssssusussnnunununnnnunnnnnnnnennnnnns 5 1 5 ALCHEMIST Study DESI N sirsiran canonar auinaconanaae ansainneen iaaa aaa aapko d a Savaa kaani 6 1 6 Central Clinical GEnOUy Oi e inaa aa E adaa NE 6 1 7 Advanced Genomics at CCG ssssssnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 6 1 8 Recurrence BIOpSy ioiii aseni n painaa aaae EEEE aa iai aaan aA E Ea EA anaa 6 20 ODJECU OS hace essen tecsccae eae EA EAEE NSR T 2 1 Primary ODJCCUVOS ia E ten eccaseels leteccsatuven terceemenneee 7 222 Secondary ODS CEIV CS sairin a NA 7 2 3 Exploratory Other ODJectivesS sss ccssiscsscesses cscs sccssacgsceaustscanecexssessusncescdeavexsteusessnceueesenestsasceuseeateustenie 7 3 0 Patient Pre registration Registration Eligibility Criteria ssscccsssscccssssssssssssssssssssssssssesees 7 3 1 Patient Pre registration Eligibility Criteria ssussnsunnunnunnunnunnnnnnnunnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 7 Note Post surgical patients should proceed to registration immediately following pre VS USER UNO sisi a ca aed ca cco Seen ee cued veda cach ceed nce da weed natant ened detec eon 8 3 2 Patient Registration Eligibility Criteria s ssussussunnunnnnnnnunnnnnunnunnununnunnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 8 4 0 Patient Pre Registration
11. R and ALK wild type lung cancers to allow subsequent development of targeted therapies against genotype defined subpopulations in the adjuvant and recurrent settings 2 2 2 To cross validate local genotyping assays for EGFR and ALK with a central reference standard Exploratory Other Objectives 2 3 1 To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence 3 0 PATIENT PRE REGISTRATION REGISTRATION ELIGIBILITY CRITERIA 3 1 Patient Pre registration Eligibility Criteria For pre surgical patients e Suspected diagnosis of resectable non small cell lung cancer e Suspected clinical stage of IIA II or large IB defined as size gt 4cm For post surgical patients e Completely resected non small cell lung cancer e Pathologic stage IIIA II or IB defined as size gt 4 cm For all patients e ECOG Performance Status 0 1 e No patients who have received neoadjuvant therapy chemo or radio therapy for this lung cancer e Age gt 18 years e No prior or concurrent malignancies within 5 years except non melanoma skin carcinoma or in situ carcinomas A secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216 e No prior treatment with agents targeting EGFR mutation or ALK rearrangement e Non lactating and no patients known to be pregnant e Patients who have had local genotyping are eligible regardless of the loc
12. Tel 507 266 6247 schultz chelsea mayo edu Laboratory Information Response Genetics Stephanie H Astrow PhD MBA Response Genetics Inc 1640 Marengo St Los Angeles CA 90033 Tel 323 276 6062 sastrow responsegenetics com NCI Center for Cancer Genomics Biospecimen Core Resource Julie M Gastier Foster PI Kristen Leraas Program Manager Nationwide Children s Hospital 700 Children s Drive Columbus OH 43205 Tel 614 355 3589 kristen leraas nationwidechildrens org Document History Effective Date Activation 08 18 14 Update 01 03 15 15 Version Date 02 09 15 2 Update 01 A151216 Patient Pre Registration Eligibility Criteria e For pre surgical patients Suspected resectable NSCLC and suspected stage IB 4 cm II or IIIA e For post surgical patients Complete resection of NSCLC path stage IB 4 cm II or IA e For all patients ECOG Performance Status 0 1 No patients who have received neoadjuvant therapy chemotherapy or radiotherapy Age gt 18 years No prior or concurrent malignancies w in 5 years except non melanoma skin CA or in situ CA No prior treatment with agents targeting EGFR mutation or ALK rearrangement Non pregnant and non lactating Patients with local genotyping are eligible regardless of the local result Patient Registration Eligibility Criteria e Completely resected stage IB 4 cm IJ or WIA non squamous NSCLC e Adequate FFPE tissue available for central EGFR and ALK genotyping e Patients
13. Update 01 03 15 2015 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY PROTOCOL UPDATE FOR ALLIANCE A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial ALCHEMIST A screening trial for A081105 and E4512 Update Status Change Eligibility changes _ Activation Therapy Dose Modifications Study Calendar changes Closure Informed Consent changes Suspension temporary closure Scientific Statistical Considerations changes Reactivation Data Submission Forms changes Editorial Administrative changes Other IRB review of this update is required within 90 days Expedited review is allowed Please follow your local IRB guidelines Cover Page Geoffrey Oxnard replaces Pasi Janne as the Study Chair Schema The schema has been reorganized to match Section 3 0 There are now pre registration eligibility criteria for pre surgical patients post surgical patients and for all patients e Under the for all patients criteria the following changes have been made The criteria No diagnosis of interstitial pulmonary fibrosis or other lung disease has been deleted The criteria No patients with local genotyping showing both wild type EGFR and ALK has been removed from this section The new criteria explaining that patients are eligible regardless of any local genotyping results has been added The criteria about patients with a K ras mutation being ineligible has
14. a aiae 13 7 1 SAIN ES VA A A E A E E EE E A I E E E 13 7 2 Baseline Clinical Information ssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnna 14 7 3 CHnical FOMOW Up Platis eaea a a eee ea 14 7 4 FAWN MINES isisisi aa aaa aaa 14 7 5 Sampie SIZO ci satiate came cated eeticae ak as eas sue aa tecen cet caneuems opsuuecaecaeeecesstastcaioees 15 7 6 Analysis Plai asrni 15 8 0 Ethical and Privacy Considerations sssssssssccecceccccccccssssssssccccccccceccccosssssssseccccecccecccsssssssssssccceee 16 8 1 Restricted Access to Genomic Data ssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 16 90 FRETERENCES eaoaai a a aae a aai 18 APPENDIX I aruinn EN E E 19 APPEND Mennen a a a a a ia 20 Version Date 02 09 15 4 Update 01 1 0 A151216 INTRODUCTION 1 1 1 2 1 3 1 4 Selecting Therapies Based Upon Lung Cancer Genotype The management of advanced lung adenocarcinoma has been transformed by the identification of targetable genotypes in a significant proportion of patients Genotyping advanced lung adenocarcinomas for EGFR mutations and ALK rearrangements is now a routine part of care as these genotypes indicate unique sensitivity to treatment with tyrosine kinase inhibitors TKIs such as erlotinib and crizotinib 1 2 However these highly active targeted therapies do not lead to cures resistance invariably develops Adjuvant Targeted Ther
15. al result Version Date 02 09 15 di Update 01 4 0 A151216 Note Post surgical patients should proceed to registration immediately following pre 3 2 registration Patient Registration Eligibility Criteria e Completely resected non squamous NSCLC Eligible histologic subtypes include adenocarcinoma adenosquamous carcinoma or large cell poorly differentiated NSCLC as long aS squamous carcinoma is not favored Patients with pure squamous carcinoma are not eligible e Pathologic stage IIIA II or large IB defined as size gt 4cm e Adequate FFPE tissue available for central EGFR and ALK genotyping for all patients including those already locally tested for EGFR and ALK e In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial patients must register within the following eligibility windows depending on the adjuvant treatment approach 1 Ifno adjuvant therapy register patient within 75 days following surgery 2 If adjuvant chemotherapy only register patient within 165 days following surgery 3 If adjuvant chemotherapy and radiation register patient within 225 days following surgery PATIENT PRE REGISTRATION AND REGISTRATION All patients will pre register to A151216 Those patients that have already had surgery will complete the registration process at the same time as pre registration Pre op patients will be pre registered and will then be registered following surgery
16. and Registrations ssssscsssssssscccssssssssssssssssssssssccsssccccccsscssssssssssssees 8 4 1 CTSU registration reg le Ment visiviiscasciissiieciscasasissicsrsdaniansasstasenvasensteviaiaienntenuretisaenreseecienrieris 8 4 2 OPEN Registration System Access Requirements ssssussussusunsunsunnunnunnunnununnunnnnnnnnnnnnnnnnnnnnn nnn 9 4 3 Pr repistration Reg ire mentsios iaaea aeai adain 9 4 4 Patient Pre registration Procedures sssssussssusunsunnnnunnnnnnnununnnnunnnnunnununnnnnnnunnnnnnnnnnnnnnnnnnnnnn nnmnnn 9 4 5 Patient Registration Procedures i sania iinnneionnnin 9 5 0 Specimen Collection and Submission ssceceeeeeccccosossssssecceececccccosossssssecccececcccecccssssssssesccccceceessso 10 5 1 Specimen Submission Overview and Timeline ssssssnssnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 10 5 2 Tissue Preparati oii ssacesccccescsdescccesescassecnnssceccessntensacessewesssnenascessscevatetanosextueenscseascceesesesaseensccensebenstueans 11 5 3 Specimen Submission using the Alliance Biospecimen Management System 12 5 4 Inadequate Submissions sssssussunennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nannan 13 6 0 Clinical Data Requirements seisein E N EEEO Nar a 13 6 1 BEE WUD nonoi ar a anon ecew eee eee extes 13 10 jStALISTICAL C ONSIC EL AUTIONS coccessec deci eosSeesteceadescaccewuehecevececadeteneducsu dia Gacaacecunccdccecceakeeiteces EAEE
17. apies To determine whether highly active TKIs can improve cure rates they must be studied in earlier stage disease I III EGFR TKIs like erlotinib and gefitinib have been studied in the adjuvant setting but not in genotype selected populations 3 4 For this reason studies randomizing genotype selected lung cancer populations to TKI or placebo are under development both for erlotinib and crizotinib To make these studies feasible large numbers of resected lung adenocarcinomas will need to undergo screening for EGFR mutations and ALK rearrangements Because genotyping of resected lung cancers is not a routine part of clinical care a screening trial is needed to identify EGFR mutant and ALK rearranged lung cancers Managing Resected lung Adenocarcinoma as a Genomically Diverse Disease This study attempts to change the paradigm of adjuvant therapy in NSCLC towards the delivery of personalized genotype directed therapies The power of broad genomic characterization has already been demonstrated in advanced disease highlighted by the work of the Lung Cancer Mutation Consortium 5 This collaboration of academic cancer centers committed to performing genotyping of 10 different genes for 1000 lung cancer patients accelerating accrual to biomarker based clinical trials This current trial A151216 ALCHEMIST now lays the groundwork for applying the same paradigm to resected lung adenocarcinoma The ALCHEMIST trial will screen patients with resected
18. as long as all the registration eligibility criteria have been met Patients may be receiving adjuvant chemotherapy at the time of registration 4 1 CTSU registration requirements This study is supported by the NCI Cancer Trials Support Unit CTSU Prior to the recruitment of a patient for this study investigators must be registered members of a Cooperative Group Each investigator must have an NCI investigator number and must maintain an active investigator registration status through the annual submission of a complete investigator registration packet FDA Form 1572 with original signature current CV Supplemental Investigator Data Form with signature and Financial Disclosure Form with original signature to the Pharmaceutical Management Branch CTEP DCTD NCI These forms are available on the CTSU Web site enter credentials at https www ctsu org then click on the Register tab or by calling the PMB at 301 496 5725 Monday through Friday between 8 30 am and 4 30 pm Eastern time Each investigator or group of investigators at a clinical site must obtain IRB approval for this protocol and submit IRB approval and supporting documentation to the CTSU Regulatory Office before they can enroll patients Study centers can check the status of their registration packets by querying the Regulator Support System RSS site registration status page of the CTSU member Web site by entering credentials at https www ctsu org Requirements for CALGB
19. being followed clinical follow up will be kept to a minimum All patients will be followed until otherwise notified by the Statistical Center Patients will be contacted every 6 months to assess the following datapoints e Adjuvant therapy received Y N which agents Recurrent Y N e Date of recurrence Site of recurrence e Pathologic confirmation of recurrence Y N type of biopsy Smoking Status Dead Y N e Date of death In the instances where BCR has determined that there is not usable tissue for genomic analysis the Data Center will contact the site to let them know patient follow up may be discontinued Sites should not discontinue patient follow up before the 5 year point unless instructed to do so by the Data Center 7 44 Endpoints 7 4 1 Primary Endpoint There are two primary endpoints to this trial e Central clinical genotyping to facilitate accrual to the adjuvant Intergroup studies E4512 and A081105 as measured by rate of accrual The target accrual rate is around 16 patients per month both for patients with EGFR mutations A081105 and those with ALK rearrangements E4512 so as to allow completion of the adjuvant trials within a four year period e Feasibility of research grade FFPE tissue collection for CCG analysis as measured by adequate specimens collected per month The goal is to achieve a collection rate over 100 adequate cases per month to allow collection of at least adequate 4800 specimens
20. bmitted with the sample to RG should include the protocol number A151216 patient number and patient s initials A copy of the Shipment Packing Slip produced by BioMS must be printed and placed in the shipment with the specimens Instructions for the collection of samples are included below Please be sure to use a method of shipping that is secure and traceable Extreme heat precautions should be taken when necessary Shipment on Monday through Thursday by overnight service to assure receipt is required If shipping on Friday FedEx or UPS must be used and the air bill must be marked For Saturday delivery Do not ship specimens on Saturdays 5 3 1 Tissue Block Slide Submission At the time of biospecimen submission a blank Clinical Assay Request form will be automatically printed at the same time as the standard BioMS shipping manifest This form should be completed by appropriate clinical personnel and included with the biospecimen shipment to Response Genetics It is needed independent of the BioMS shipping form for returning EGFR and ALK testing results to the clinical site Please also send a copy of the patient s pathology report to Response Genetics All tissue specimens for ALK EGFR analysis should be sent to Response Genetics RG Response Genetics Attn Director of Pharmaceutical Services Version Date 02 09 15 12 Update 01 A151216 1640 Marengo Street Suite 410 Los Angeles CA 90033 Tel 323 224 3900 x210
21. ct identifier and block number missing from the block or slides Version Date 02 09 15 21 Update 01 A151216 OVERVIEW OF TUMOR BLOCK SHIPPING 1 Fill out the Lab Requisition 2 Ensure the tissue block is 3 Place the tissue block in a Form and place in the foam labeled legibly with the slide box mailer Subject Identifier and block number written in pencil 4 Place the slide box in the 5 Ship ambient to Response foam mailer Genetics Shipping Address Response Genetics Pharmaceutical Services 1640 Marengo Street Suite 410 Los Angeles CA 90033 Version Date 02 09 15 22 Update 01 A151216 OVERVIEW OF SLIDE SHIPPING 1 Five 5 newly cut serial tissue sections cut at 10 micron plus three 3 cut at 5 micron are mounted on positively charged frosted ended slides 4 Place the slide box and the Lab Requisition Form in a foam mailer Version Date 02 09 15 2 Ensure that subject identifier and block number are written legibly in pencil on the frosted end of each Slide 3 Place the slides in a slide box 5 Ship ambient to Response Genetics Shipping Address Response Genetics Pharmaceutical Services 1640 Marengo Street Suite 410 Los Angeles CA 90033 23 Update 01
22. e clearly legible Wrap blocks in a foam pouch and place into slide container See packaging instructions PREPARATION OF TISSUE SLIDES If the tissue block is unavailable prepare tissue slides The number of slides to be submitted is five 5 10 micron sections plus three 3 5 micron sections Positively charged frosted ended slides must be used Section a single section containing tissue onto each slide Sections must be from the same tissue block Subject identifier and block number must be written legibly in pencil on the frosted end of the slide Slides must not be baked or melted Cover slips must not be used Sections must not be stained Place slides in slide box See packaging instructions IMPORTANT HIGHLIGHTS ABOUT TISSUE SAMPLE PREPARATION Tissue blocks are preferred Multiple blocks per visit should not be submitted Tissue sections must come from the same block The entire lab requisition form must be completed and include the biopsy collection date and the biopsy collection site Identifiers including subject identifier and block ID number must be entered on the requisition form and must match the identifiers on the tissue blocks or slides Only the required number of slides or a block of tissue should be submitted AVOID THE FOLLOWING Submission of the incorrect number of slides Submission of stained slides Incorrect sample packaging Incorrect and or incomplete lab requisition form e g Subje
23. e available to all eligible patients regardless of race gender or ethnic origin Accrual Targets Ethnic Category Sex Gender Males 160 4320 3396 7116 Ethnic Category Total of all subjects 4444 3556 8000 American Indian or Alaskan Native 18 Asian ooo O 0o oS 0 178 Native Hawaiian or other Pacific Islander 0O o 0 4195 CI __ 4195 3360 7555 Racial Category Total of all subjects 4444 3556 8000 Ethnic Hispanic or Latino a person of Cuban Mexican Puerto Rican South or Central Categories American or other Spanish culture or origin regardless of race The term Spanish origin can also be used in addition to Hispanic or Latino Not Hispanic or Latino Racial American Indian or Alaskan Native a person having origins in any of the original Categories peoples of North Central or South America and who maintains tribal affiliations or community attachment Asian a person having origins in any of the original peoples of the Far East Southeast Asia or the Indian subcontinent including for example Cambodia China India Japan Korea Malaysia Pakistan the Philippine Islands Thailand and Vietnam Note Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies Black or African American a person having origins in any of the black racial groups of Africa Terms such as Haitian or Negro can be used in addition to Black
24. e check with your cooperative group and follow their rules regarding membership roles and privileges 4 3 Pre registration Requirement Informed Consent The patient must be aware of the neoplastic nature of his her disease and willingly consent after being informed of the procedure to be followed the experimental nature of the therapy alternatives potential benefits side effects risks and discomforts Human protection committee approval of this protocol and consent form is required 4 4 Patient Pre registration Procedures e Pre registration to A151216 Patients will be pre registered to CALGB A151216 using the OPEN registration system OPEN may be accessed at https open ctsu org from the OPEN tab on the CTSU website at https www ctsu org or from the OPEN Registration tab on the Alliance website e If technical difficulties are experienced with OPEN during normal business hours please contact the CTSU Help Desk 1 888 823 5923 If technical difficulties are encountered with OPEN outside of normal business hours please contact 1 914 400 4198 e The OPEN system will provide the registering site with a printable confirmation of pre registration Please print the confirmation for your records Further instructional information is provided on the CTSU members website OPEN tab or within the OPEN URL For any additional questions contact the CTSU Help Desk at 1 888 823 5923 or ctsucontact westat com 4 5 Patient Registration Pr
25. encing and methylomics on paraffin embedded specimens In collaboration with CCG this study will be an opportunity to develop these technologies on clinically annotated specimens and to eventually explore the clinical significance of the Version Date 02 09 15 5 Update 01 A151216 results of this genomic research Additionally this study will create a unique opportunity to study change in genomics over time through the collection and analysis of diagnostic specimens collected at recurrence 15 ALCHEMIST Study Design The ALCHEMIST study will accrue patients that are potentially eligible for the adjuvant treatment studies A081105 and E4512 and perform central EGFR and ALK genotyping using a central reference laboratory certified by the Clinical Laboratory Improvement Amendments of 1988 CLIA Patients may either present prior to surgery with resectable NSCLC or may present following complete resection before or after adjuvant chemotherapy Eligibility is limited to those with NSCLC of a non squamous histological subtype and those with adequate performance status and organ function for future trial eligibility All subjects must submit tissue for central EGFR and ALK genotyping Patients will provide peripheral blood for matched normal DNA 1 6 Central Clinical Genotyping All patients including those with local genotyping results will have formalin fixed tissue collected for central genotyping The testing will be performed at Respon
26. ermitted to submit additional tissue to BCR so patients can be included in research genomics if adequate for research genomics BCR will communicate this to the Alliance and follow up can be re initiated Alliance will communicate to the site regarding follow up termination Version Date 02 09 15 19 Update 01 A151216 APPENDIX II Laboratory Manual for ALK EGFR Testing Tissue Submission ALCHEMIST RESPONSE GENETICS CONTACT INFORMATION Miriana Moran PhD PMP Director of Pharmaceutical Services mmoran responsegenetics com Office 323 224 3900 ext 210 Fax 323 224 3096 Sharlyn Silang Clinical Research Associate ssilang responsegenetics com Office 323 224 3900 ext 149 Fax 323 224 3096 Stephanie H Astrow PhD MBA Vice President Research amp Development sastrow responsegenetics com Office 323 276 6062 Cell 213 434 4971 Shipping Address Response Genetics Pharmaceutical Services 1640 Marengo Street Suite 410 Los Angeles CA 90033 Version Date 02 09 15 20 Update 01 A151216 BLOCK AND SLIDE PREPARATION PREPARATION OF PARAFFIN EMBEDDED TISSUE BLOCKS Tissue blocks are preferred Blocks should be submitted as soon as possible after consent is obtained Standard dimensions of block approximately 4cm x3cm If multiple blocks available submit block with most tissue do not send multiple blocks per subject The subject identifier and block number must be written on the block in pencil and b
27. ers for correlative analyses The results of these genomic studies will not be provided back to the patient or their treating physician 1 8 Recurrence Biopsy Subjects participating in the follow up portion of the ALCHEMIST study as well as those participating in the adjuvant therapeutic studies may at the discretion of the treating physician undergo a standard of care diagnostic biopsy to confirm recurrence If possible at least two core biopsies minimum should be obtained as part of this recurrence biopsy If available paraffin embedded tissue from this biopsy should be sent to the NCI CCG BCR for additional research genomics In the event that re biopsy tissue is not available if clinical genomics testing is otherwise performed on the recurrence biopsy specimen this data will be collected for research analysis as well Version Date 02 09 15 6 Update 01 A151216 2 0 OBJECTIVES 2 1 2 2 2 3 Primary Objectives 2 1 1 To centrally genotype resected lung adenocarcinomas for EGFR mutations and ALK rearrangements to facilitate accrual to randomized adjuvant studies 2 1 2 To obtain clinically annotated tumor tissue and patient matched non malignant DNA from peripheral blood as well as detailed epidemiologic and clinical follow up data to allow clinically annotated advanced genomic analyses in concert with the NCI Center for Cancer Genomics CCG Secondary Objectives 2 2 1 To characterize the natural history of EGF
28. ganizations that may have access to the patient s records A Replacement Protocol and Model Consent Document have been issued ATTACH TO THE FRONT OF EVERY COPY OF THIS PROTOCOL ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY ALLIANCE A151216 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial ALCHEMIST Study Chair Geoffrey Oxnard MD Lowe Center for Thoracic Oncology Dana Farber Cancer Institute 450 Brookline Ave Boston MA 02115 Tel 617 632 6049 geoffrey_oxnard dfci harvard edu Study Co chair Mark Watson MD Washington University Tel 314 454 7919 watsonm wustl edu SWOG Co Chair ECOG Co chair David Gandara M D Suresh Ramalingam Tel 916 734 5959 Tel 404 778 7777 david gandara ucdmc ucdavis edu suresh ramalingam emory edu Disease Committee Chair Everett Vokes MD Tel 773 702 9306 evokes medicine bsd uchicago edu Primary Statistician Secondary Statistician Sumithra Mandrekar PhD Shauna Hillman MS Tel 507 266 6724 Tel 507 284 1533 mandrekar sumithra mayo edu hillman shauna mayo edu Protocol Coordinator Colleen Watt Tel 773 702 4670 Fax 312 345 0117 cboyle uchicago edu Participating NCTN groups Alliance ECOG ACRIN NRG SWOG For NCI Use Only Version Date 02 09 2015 1 Update 01 A151216 Study Contacts Alliance Statistical and Data Center Mayo Clinic 200 First St SW Rochester MN 55905 Protocol Resources A151216 Data Manager Chelsea Schultz
29. genomic research Once the results from RG have been received patients will be considered for one of the treatment trials if they are for either EGFR or ALK Patients that are for EGFR and ALK will continued to be followed on A151216 If a patient is found to be locally for both EGFR and ALK but are from the RG results they may be entered onto one of the treatment trials Following registration a CRA will complete an epidemiological questionnaire with eligible study participants to be used for comprehensive clinical annotation of the planned research genomics at CCG 5 0 SPECIMEN COLLECTION AND SUBMISSION 5 1 Specimen Submission Overview and Timeline Blood All patients will have blood obtained at any point after pre registration up to 30 days following registration Blood should be shipped to the BCR within week of collection 1 Tumor blocks or cut slides and tissue scrolls Following registration blocks or slides will be submitted to Response Genetics RG laboratory for EGFR and ALK testing If Slides are submitted to RG then sites must submit tissue scrolls to the BCR Tissue scrolls are shavings from the pathology block Recurrence Biopsy If a biopsy is done at recurrence tissue will be submitted to the BCR 5 1 1 Blood Collection and Submission for All Patients Whole blood 5 10ml in an EDTA tube will be obtained at any point following pre registration up until 30 days following registration Submit the b
30. ication of participants and includes requirements for data security Controlled access data are for General Research Use 1 e usable for any genetic studies there are no data use restrictions with respect tofield of study and users may apply data to any legitimate research including non cancer research related discovery Version Date 02 09 15 17 Update 01 9 0 A151216 REFERENCES Rosell R Moran T Queralt C Porta R Cardenal F Camps C et al Screening for epidermal growth factor receptor mutations in lung cancer N Engl J Med 2009 361 958 67 Kwak EL Bang Y J Camidge DR Shaw AT Solomon B Maki RG et al Anaplastic Lymphoma Kinase Inhibition in Non Small Cell Lung Cancer N Engl J Med 2010 363 1693 703 Richardson F Richardson K Sennello G Young D Orlov S Papai Szekely Z et al Biomarker analysis from completely resected NSCLC patients enrolled in an adjuvant erlotinib clinical trial RADIANT ASCO Meeting Abstracts 2009 27 7520 Goss GD O Callaghan C Lorimer I Tsao M S Masters GA Jett J et al Gefitinib Versus Placebo in Completely Resected Non Small Cell Lung Cancer Results of the NCIC CTG BR19 Study J Clin Oncol 2013 Johnson BE Kris MG Berry LD Kwiatkowski DJ Iafrate AJ Varella Garcia M et al A multicenter effort to identify driver mutations and employ targeted therapy in patients with lung adenocarcinomas The Lung Cancer Mutation Consortium LCMC ASCO Meeting Abstracts 2013 31 8019
31. lood to the NCI CCG Biospecimen Core Resource BCR within 1 week of collection Blood may be stored at 4 C until shipping Ship at room temperature 5 1 2 Tissue Submission for All Patients Following registration sites will submit tissue for EGFR ALK genotyping and research genomics Two options are 2 Submit a clinical tissue block to Response Genetics RG RG will then forward the remaining tissue to the BCR 3 Submit slides to RG and tissue scrolls to the BCR Tissue scrolls are shavings from the pathology block A de identified pathology report should accompany the tissue submission to RG The pathology report will not be forwarded to BCR Results from the EGFR ALK testing at RG will be available and sent to the sites within 14 business days Patients that are EGFR mut and or ALK will be assessed for the adjuvant treatment trials A081105 and ECOG E4512 respectively Version Date 02 09 15 10 Update 01 A151216 5 1 3 Tissue Submission at Progression for All Patients Patients with a recurrence biopsy available will have tissue submitted to the BCR 5 2 Tissue Preparation See Appendix II for further information regarding block and slide submission to Response Genetics RG Study Tissue Block At the time of surgical resection and gross pathology review an additional segment of grossly apparent primary tumor tissue will be embedded for study purposes only This tumor tissue block will not be returned to
32. number of evaluable patients where an evaluable patient is one who has a local assessment result and has submitted tissue for central assessment An agreement rate of 90 or higher between the local assay and the central assessment will be deemed acceptable The 95 confidence intervals for 90 success rates such that the lower limit is at least 80 or higher are given in the following table for different sample sizes Sample Size Number of successes _ 95 Confidence Interval lower upper 100 90 82 4 95 1 150 135 84 0 94 3 200 180 85 0 93 8 250 225 85 6 93 4 7 4 3 Exploratory Other Endpoint e Spectrum of new mutations identified at recurrence Genomic analysis will be performed on tissue collected at time of recurrence and compared to baseline genomics New mutations in key oncogenes and tumor suppressor genes PIK3CA PTEN etc will be quantified It is hypothesized that a greater number of new alterations will be identified in patients whom received adjuvant chemotherapy as opposed to those not receiving adjuvant chemotherapy 7 5 Sample Size The sample size will depend partially upon the prevalence of EGFR mutations and ALK rearrangements and partially upon the degree of selection used when investigators are accruing patients With no clinical selection up to 8000 patients will need to be screened to fully accrue the randomized adjuvant studies This is because ALK rearrangements are present in 4 5 of lung adenocarcinoma such
33. ocedures Patients pre registered post operatively will complete the registration process at the same time as pre registration Following confirmation of registration eligibility criteria for those patients registered pre surgery the CRA will register the patients by entering the Alliance patient ID number assigned at pre registration into the OPEN registration system The OPEN system will provide the institution with a printable confirmation of registration and treatment information Please print this confirmation for your records Version Date 02 09 15 9 Update 01 A151216 Patients with a local EGFR mut or ALK test will register to A151216 and may proceed to be screened for the appropriate adjuvant treatment trial so long as they also will have their tissue block or slides submitted to Response Genetics for genotyping These patients should have blood and tissue submitted for genomic research These patients do not need to wait the 14 days for confirmation of the positive test to enter the treatment trial If the central laboratory RG does not confirm the local positive test patients may still be registered to the appropriate adjuvant treatment trial but will not be included in the analysis of the primary endpoint of the treatment trial Patients with a local EGFR mut negative and ALK negative test will register to A151216 and submit their blocks or slides to RG for genotyping These patients should have blood and tissue submitted for
34. or African American Native Hawaiian or other Pacific Islander a person having origins in any of the original peoples of Hawaii Guam Samoa or other Pacific Islands White a person having origins in any of the original peoples of Europe the Middle East or North Africa 8 0 ETHICAL AND PRIVACY CONSIDERATIONS 8 1 Restricted Access to Genomic Data The research genomic studies will generate genetic data unique to an individual genetic fingerprints or genotypes These data are not directly tied to an identified individual and Version Date 02 09 15 16 Update 01 A151216 the clinical information associated with these data will be de identified Nevertheless a risk exists that the genetic data could lead to the re identification of a participant or relative Consequently NIH policy is that individual genetic data from the characterization studies are kept in a restricted access tier of the database To be authorized to access the restricted tier of data Investigators must submit an application to a Data Access Committee DAC of the National Institutes of Health designated to review applications for the Alchemist initiative Upon approval by the DAC that the access request is for bona fide research purposes the Investigator scientists under their control and their institution must subscribe to a Data Use Certification DUC that controls their ability to access the data redistribute the data prohibits the re identif
35. over a four year period Importantly this collection rate will depend upon specimen adequacy reports provided by the CCG 7 4 2 Secondary Endpoints There are two secondary endpoints for this trial e 2 year disease free survival DFS rate for lung cancers which are wild type for EGFR and ALK Using genomics performed at CCG DFS rate will be calculated for Version Date 02 09 15 14 Update 01 A151216 each genotype defined population constituting greater than 1 of the study cohort DFS is defined as the time from resection to the earliest of documented disease recurrence confirmed by biopsy development of a new lung cancer confirmed by biopsy or death from any cause We estimate at least 80 patients in each of these rare genotype defined subsets which will allow estimation of the 2 year DFS rate within 11 2 points with 90 confidence This will serve as a historical control for future single arm phase II trials of targeted adjuvant agents in these populations e Agreement of local genotyping methods direct sequencing of EGFR ALK FISH with central CLIA genotyping Each locally deemed EGFR mutant or wild type patient will also be classified by central assessment Similarly each patient deemed locally as ALK rearranged or not by FISH will be classified by the central assessment For each locally used assay agreement will be defined as the proportion of patients deemed mutant or wild type by local and central assessment divided by the
36. rocess at the same time as pre registration has been added as a first sentence to this section In the second sentence the statement for those patients registered pre surgery has also been added The previous 3 paragraph has been included in paragraph 2 A new third paragraph has been added to address the inclusion of locally negative patients Section 5 1 Specimen Submission Overview and Timeline This entire section and sub sections have been re ordered to match the sequence of events Blood will be collected at any point following pre registration up until 30 days after registration Once blood is obtained it should be shipped to the BCR within 1 week of collection We have also clarified that tissue should be submitted to Response Genetics following registration Section 5 1 2 Registration Blood and Tissue Submission The definition of tissue scrolls has been added to the second option listed The previous discussion about the epidemiological questionnaire has been taken out of this section and included in the registration section at the end of Section 4 5 Section 5 1 3 Tissue Submission at Progression for All Patients The title of this section has been updated from Progression Section 5 2 Tissue Preparation The title of this section has been updated from Tissue Submission Section 5 3 Specimen Submission using the Alliance Biospecimen Management System The information about the blood submis
37. se Genetics Los Angeles CA a commercial CLIA certified laboratory ALK FISH will be performed using the Vysis break apart probe and EGFR genotyping will be performed by sequencing of exons 18 21 Genotyping results are expected to be provided to the treating clinician within 14 business days of submission so they can be used to determine eligibility for the randomized adjuvant studies or to confirm the local results Results will also be reported at intervals to the study team for upload into the Alliance database 1 7 Advanced Genomics at CCG In addition to the commercial genotyping at Response Genetics tissue will be collected for research genomics by CCG For those patients with a block available this will be forwarded to the CCG after clinical testing at Response Genetics For those patients without a block available 10 micron scrolls should be cut from a block and submitted the thicker sections reduce oxidative tissue damage seen with standard thickness slides A peripheral blood specimen will also be collected and sent to the CCG BCR to be used as a source of non malignant germline DNA Specimens will be coded Over the course of the study the CCG will perform advanced genomic analysis of the resected lung cancer specimens in a research non CLIA environment Following completion of the genomic analysis the results can be matched with the clinical follow up results using a link between the samples coded and the patient identifi
38. sion has been added as Section 5 1 1 and therefore has been removed as this section Subsequent sections has been renumbered as appropriate In the new fifth paragraph information about the pathology report submission has been added Section 5 3 1 Tissue Block Slide Submission Information about submitting the pathology report to Response Genetics has been added at the end of the first paragraph Section 5 3 2 Scroll if applicable Blood and Recurrence Biopsy Submission Kristen Leraas phone number has been updated Section 6 1 Follow up The following information has been added to the end of the second bullet point This will be a very small percentage of patients who are registered pre operatively and are found at surgery not to be eligible to participate on A151216 Section 7 4 2 Secondary Endpoints Under the second bullet point changes have been made to the first 4 sentences to address the addition of the locally negative patients as eligible patients Section 8 1 Restricted Access to Genomic Data At the end of the first sentence of the second paragraph the phrase Exceptional Responders Initiative has been corrected to read Alchemist initiative APPENDIXI At the beginning of the diagram the statement Eligible patient pre registers registers to A151216 has been added MODEL CONSENT FORM UPDATES Under Who will see my Medical Information section Response Genetics has been added to the list of or
39. that 8000 patients must be screened to identify the 366 subjects for the crizotinib study However if investigators decide to use clinical selection methods to determine which patients to screen and primarily accrue never smokers then half as many patients must be screened EGFR mutations and ALK rearrangements are twice as prevalent in never smokers as in the general adenocarcinoma population Alternatively some centers may genotype resected cancers locally and then accrue patients with a known EGFR mutation or ALK rearrangement this would further decrease the total number of patients needed to be centrally genotyped to achieve the study aims 7 6 Analysis Plan Accrual rate to the adjuvant erlotinib and crizotinib studies will be monitored every 3 months and discussed between the study teams coordinating the ALCHEMIST study and the adjuvant studies If accrual is inadequate then the ALCHEMIST study will initiate strategies to Version Date 02 09 15 15 Update 01 A151216 improve accrual including opening the screening study at new centers and developing strategies for genotyping at participating centers to improve catchment Specimen collection rate will also be monitored every 3 months and discussed between the ALCHEMIST study team and the CCG If collection of adequate specimens is insufficient then the ALCHEMIST study will initiate strategies to improve specimen adequacy 7 7 Inclusion of Women and Minorities This study will b
40. ue Scrolls The site pathologist should also identify one block of primary tumor tissue from the case that is representative of the histological diagnosis and document tumor cellularity by histological review preferably this will be the same block from which slides were cut for shipment to Response Genetics One 5 6 micron section slide should be cut and stained with H E followed by a number of 10 micron tissue sections scrolls calculated as follows Number of tissue sections 12 0 01 L W where L W are the approximate cross sectional length and width of the tissue surface in mm Site pathologists may use the scroll calculator on the A151216 webpage to quickly determine the number of sections needed based upon tissue cross sectional area Scrolls should be sealed inside a microcentrifuge tube and a final 5 6 micron section should be cut and stained with H E The sealed tube of tissue scrolls and both H E stained referenced slides should be shipped to the BCR on the same day of sectioning To ensure rapid processing note that blocks should not be sectioned or shipped on a Friday Saturday or a day before a holiday Version Date 02 09 15 11 Update 01 A151216 Submission at Recurrence Patients undergoing a diagnostic biopsy at recurrence will have tissue submitted to the BCR if available If there were clinical genomics done on a recurrence specimen for any patient regardless of whether or not there is recurrence tiss
41. ue available for submission sites should submit the molecular report on the recurrence specimen 5 3 Specimen Submission using the Alliance Biospecimen Management System USE OF THE ALLIANCE BIOSPECIMEN MANAGEMENT SYSTEM BioMS IS MANDATORY AND ALL SPECIMENS MUST BE LOGGED AND SHIPPED VIA THIS SYSTEM BioMS is a web based system for logging and tracking all biospecimens collected on Alliance trials Authorized individuals may access BioMS at the following URL http bioms allianceforclinicaltrialsinoncology org using most standard web browsers Safari Firefox Internet Explorer For information on using the BioMS system please refer to the Help links on the BioMS web page to access the on line user manual FAQs and training videos To report technical problems such as login issues or application errors please contact 1 855 55 BIOMS or Bioms alliancenctn org For assistance in using the application or questions or problems related to specific specimen logging please contact 1 855 55 BIOMS or Bioms alliancenctn org After logging collected specimens in BioMS the system will create a shipping manifest This shipping manifest must be printed and placed in the shipment container with the specimens All submitted specimens must be labeled with the protocol number A151216 Alliance patient number patient s initials and date and type of specimen collected e g serum whole blood The de identified pathology report being su
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