Knight Cancer Institute Cancer Early Detection Advanced Research Center (CEDAR) Call for Clinical Matched Case Control Sample Collection

Transcription

1 Knight Cancer Institute Cancer Early Detection Advanced Research Center (CEDAR) Call for Clinical Matched Case Control Sample Collection IMPORTANT DATE Proposals should be submitted by Friday 1 st December 2017 to be considered for review at the corresponding committee meeting. CEDAR will make a final decision by 1 st January 2018 and notify awardees shortly afterwards. PROGRAM OVERVIEW The Cancer Early Detection Advanced Research (CEDAR) Center wishes to engage the clinical research community in an effort to collect specimens from individuals suspected of having cancer. CEDAR will provide resources to achieve the collections and is seeking proposals for the procurement of matched case/control samples (blood, tissue, urine, feces, sputum or other fluids) from participants about to undergo a diagnostic evaluation. Investigators leading these collection protocols will be included in relevant CEDAR disease working groups (currently Breast, Prostate, Multiple Myeloma, Lung working groups are meeting). CEDAR resources may be leveraged for new or existing collections for the investigator s own scientific research. The scope of this request is limited to the initial sample collection. The use and/or analysis of samples is outside of scope for this request. CEDAR s goal is to provide collected samples to CEDAR approved projects for the discovery or validation of biomarkers that distinguish those with cancer from those who do not have cancer. CEDAR considers individuals with in situ disease to be neither case nor control. Samples from participants with in situ disease should be collected, if possible, in addition to cases and controls. As many as five different disease types will be selected for CEDAR funding. Collaborative efforts with multiple clinical centers will be considered, but are not preferred. CEDAR will provide core funding to support the costs associated with sample collection. The proposal anticipates flexible and creative arrangements between applicants and CEDAR staff that seek to achieve the greatest possible efficiency and quality for the sample collection efforts. Thus, applicants may consider proposing that staff collecting the samples reside in the applicant s team or may propose the involvement of appropriate CEDAR staff. In addition to samples, if they are outside of OHSU, a minimum relevant data set must be collected and the capability to retrieve additional data from medical records must be ensured. Such a minimum set must include the patient s full name, date of birth, primary residence address, institution and institutional MRN, any unique clinical identifier used to identify the patient and the sample by the institution. Please see the Participant Consent section below for details on key requirements regarding any non-cedar clinical protocol and consent that may be used. Assurances of institutional approval for unrestricted use of the samples and long term access to clinical data by CEDAR personnel are required of any proposals external to OHSU. BEFORE YOU SUBMIT CHECKLIST Have you read the General and Sample Requirements? Sections A & B Have you read the Eligibility Criteria and Review Process? Section C Have you completed your two-page Project Proposal and Budget Form? Sections D & E If you have completed all of the above, then please submit your application here. Documents may be uploaded in Word or PDF format, as separate files or as one combined document. Please contact Bartu Ahiska at ahiska@ohsu.edu with questions. CEDAR Seed Clinical Cohort Award 1

2 SECTION A: General Requirements OVERALL MINIMUM REQUIREMENT VISUAL: PARTICIPANT CONSENT You will need to address/confirm how you will meet the following requirements in your project proposal: Consent on CEDAR IRB Repository Protocol or other protocol that allows CEDAR Repository the following access: Identifiable storage of specimens and data for future genetic research studies, access to excess tissue from diagnostic or surgical procedures, re-contact of patients, and access to medical records for CEDAR monitoring of outcomes in perpetuity. If using a protocol other than CEDAR s IRB Repository Protocol, please include the IRB number and complete protocol with your proposal. If no approved protocol exists, document your intent to submit (in Heading 1 of the Project Proposal) and provide the protocol to CEDAR once IRB approval has been granted. A mechanism must be developed to ensure that CEDAR scientists are fully authorized to work with both the samples and patient data, including Protected Health Information (PHI) and that the non-cedar protocol is maintained in active form for the duration of the planned research, which may extend beyond 10 years. Collection centers are encouraged to consent participants for additional samples/data as they see fit for their own purposes. CEDAR Seed Clinical Cohort Award 2

3 SECTION B: Sample Requirements OVERVIEW OF SAMPLE NUMBERS CEDAR believes samples from patients suspected of harboring cancer and referred for diagnostic evaluation of cancer will be of the highest value. Participants should have at least a 10% and no more than 75% likelihood of having cancer prior to diagnosis. Following the diagnostic evaluation, participants will become cancer cases (when diagnosed with invasive cancer) or controls (when the diagnostic evaluation reveals no lesion or only benign lesions), or in situ cases (when diagnosis reveals in situ disease). Resulting population Min./year Max./year Controls Cancer In situ None 100 SAMPLE REQUIREMENTS As many sample types relevant to disease types are preferred All samples are collected prior to definitive diagnosis (i.e. biopsy), and cases/controls should share the same diagnostic procedures (imaging, biopsy, etc.) Samples must be received by CEDAR within 2 hours of collection. If this time frame is not possible, describe the amount of time that would be possible. CEDAR will consider times of up to 3 days Sample collection types Required collection amount Whole blood* 30ml Urine Suggest amount in proposal Fecal Suggest amount in proposal Saliva Suggest amount in proposal Other Suggest amount in proposal * Required samples; we will supply the tubes that are needed TISSUE (OPTIONAL, BUT PREFERRED) If possible, proposals should collect biopsy material from biopsied lesions (or areas under evaluation) from both cases and controls that can be used for research purposes. Surgical specimens are encouraged in addition to biopsy samples in circumstances where biopsy tissue could not be acquired. Tissue Preferred minimum amount Required sample preparation Other requirements Biopsy Resection } 100mg 50% in OCT (frozen on dry ice at biopsy time); 50% for FFPE Must be from 2 different locations on mass CEDAR Seed Clinical Cohort Award 3

4 SECTION C: Eligibility Criteria and Review Process ELIGIBILITY Teams can be led by OHSU faculty or CEDAR Scientists. Projects may be an extension of other work, but cannot overlap with any funded project or be used as bridging support for projects for which funding has lapsed. REVIEW PROCESS Project Proposals will be reviewed by the CEDAR Seed review committee. Only applications that meet our eligibility criteria will be considered. Each proposal will be evaluated for: The problem (20%) A priority for CEDAR is to promote outstanding research addressing an important problem in early cancer detection. Do the samples help CEDAR approved project in the discovery or validation of biomarkers that distinguish those with cancer from those who do not have cancer? If the sample collection aims are achieved, will our repository and scientific knowledge be significantly advanced? Quality and efficiency (20%) Priority will be given to well-developed projects where samples are collected with the greatest quality while making efficient use-of-funds. Are samples collected wisely with sufficient quality? Are the funds used efficiently, and will the resources be sufficient to complete the project on-time and on-budget? Does the project require the grant money? Are there alternative sources of funding that are readily available? Innovation (20%) The award mechanism is designed to foster creative solutions that address a critical market need, or generate novel results that are likely to open new avenues of cancer investigation. Does the project make use of flexible and creative arrangements between applicants and CEDAR staff that seek to achieve the greatest possible method for the sample collection efforts? Are the samples likely to facilitate new avenues of cancer investigation? The team (20%) Projects must demonstrate that the team has appropriate expertise to complete the aims to a high standard, and crucially, that there is an integrated clinical and research effort. Does the team have the appropriate expertise to complete the project with high scientific quality? Does the project integrate clinical and research teams, with the right people to facilitate sample collection? Clinical and regulatory feasibility (20%) Priority will be given to well-developed projects that address or confirm how they will meet regulatory requirements and integrate into a clinical setting. Does the proposal address/confirm consent on CEDAR IRB Repository Protocol or other protocol that allows CEDAR Repository the following access: Identifiable storage of specimens and data for future genetic research studies, access to excess tissue from diagnostic or surgical procedures, re-contact of patients, and access to medical records for CEDAR monitoring of outcomes in perpetuity? If using a protocol other than CEDAR s IRB Repository Protocol, does the proposal include an IRB number and complete protocol? If no approved protocol exists, does the proposal document an intent to submit and provide the protocol to CEDAR once IRB approval has been granted? A mechanism must be developed to ensure that CEDAR scientists are fully authorized to work with both the samples and patient data, including PHI and that the non-cedar protocol is maintained in active form for the duration of the planned research, which may extend beyond 10 years. Are potential barriers recognized, and what are the plans to overcome them? CEDAR Seed Clinical Cohort Award 4

5 SECTION D: Project Proposal Requirements PROJECT PROPOSAL Please use the template on the next page, and limit proposals to two pages (not counting references). To be considered, the following information must be included and labeled in the proposal with the same headers as below: Heading 1: Participant Consent State the IRB protocol you propose to use for consent. The CEDAR repository protocol can be modified to collect your proposed specimens, but if you have another protocol you would like to use, state your intent to use another protocol and why If using a protocol other than CEDAR repository to consent participants, state the IRB # Describe who will be consenting the patients Heading 2: Patient Identification Define how you will select patients that have >10% and <75% risk prior to clinical biopsy to determine diagnosis Define how you will select screening negative participants if you are including this in your proposal Heading 3: Patient Population Describe what patient populations you expect to collect (e.g. sex, age, diversity) Describe how many cancer cases, controls, in situ, or screening negative samples are attainable; please include a justification Heading 4: Sample Collection Describe the sample types you will collect (blood, urine, tissue, etc.) and how they will be collected Describe the samples you will collect from Screen Negatives if these are included in your proposal Describe the sample amounts to be collected for each sample type Describe the collection vesicle requirements (CEDAR will provide collection vesicles) for each sample type Describe the time it will take from collection until handing off to the CEDAR Repository for each sample type Describe where the sample collections may take place (where on OHSU's campus it usually occurs) Describe current staff available for this project and any needed additional staffing Budget and justification Please use the Budget Form (Section E) to give a description of your use-of-funds by major categories, and details of any other active funding sources available for the project CEDAR Seed Clinical Cohort Award 5

6 Formatting requirements: Please use the template below using font size 10 points and one of the following recommended fonts: Arial, Calibri, Georgia, Helvetica, Palatino Linotype. Participant Consent Patient Identification CEDAR Seed Clinical Cohort Award 6

7 Patient Population Sample Collection CEDAR Seed Clinical Cohort Award 7

8 SECTION E: Budget Form BUDGET AND JUSTIFICATION We recommend that you organize your budget into the categories below (as applicable). Allowable costs include non-cedar personnel, supplies, and other expenses such as for any equipment or collection support (F&A allowed). Equipment that is essential for the study, and is not otherwise available, may be requested. Please include a justification for why that equipment is essential and why you cannot use existing equipment. We will consider awarding proposals with a range of budget sizes; the most important aspect is that budgets are justified, and sample collection efforts are efficient and with sufficient quality. Budget category Cost ($) Non-CEDAR personnel (List each with Role, FTE and OPE) Supplies Equipment Other Total cost Total cost per sample Please give a justification of your budget by major categories. CEDAR Seed Clinical Cohort Award 8