JULY 2016 NOTE TO POTENTIAL APPLICANTS: With nearly 300 approved applications utilizing Colon CFR data and/or biospecimens, overlapping research questions is becoming all the more frequent. Thus, take notice that the same CCFR data may be shared with multiple investigators, and is done so on a first come basis. The proposed analyses may vary a little or a lot and the CCFR data contribution to overlapping projects may also vary. No one investigator has exclusive rights to the CCFR data that is shared. While we take effort to point out prior applications with similar themes, we make no assurances of having made a comprehensive search. You are strongly encouraged to review the list of approved CCFR applications on the “Collaboration” link in the main menu at , and to contact investigators with similar projects to avoid surprises.
APPLICATION FOR COLLABORATIONWITH THE
COLON CANCER FAMILY REGISTRY (Colon CFR)
TITLE OF PROJECT:I.Investigator Data
Principal Investigator:
/Job Title:
Institution:
/Department:
Email address:
Address:
City:
/State:
Zip:
/Country:
Telephone Number:
/FAX Number:
*24 hour number is required for Biological Hazardous Material:
II.CCFR COLLABORATORS
CCFR Siteand Site Principal Investigator
/Check which apply (if known)
Colon CFR Administrative Center: Cedars-Sinai, Site PI: Robert Haile, DrPH
Australasian Colorectal Cancer Family Study, Site PI: Mark A. Jenkins, PhD
Cedars-Sinai Colorectal Cancer Family Registry, Site PI:Jane Figueiredo, PhD
Hawaii Family Registry of Colon Cancer, Site PI: Loic Le Marchand, MD, PhD
Mayo Colorectal Cancer Family Registry, Site PI: Noralane Lindor, MD
Ontario Familial Colorectal Cancer Registry, Site PI: Steve Gallinger, MD
Seattle Familial Colorectal Cancer Registry, Site PI: Polly Newcomb, PhD
Other Collaborating Investigator(s) and Affiliation(s)
A.STUDY DESIGN: Provide a brief description of the proposed research to use data/biospecimens from the Colon CFR (1-2 pages).
1.Abstract:
2.Specific Aims:
3.Background and Significance: State the purpose and rationale of the researchincluding why the resources of the Colon CFR are needed for the study
4.Preliminary Data: Provide evidenceof experience in analyzing data and/or biospecimens requested.
5.Study Design: Describe the design you will be using and the data that you will be requesting from the Colon CFR including justification of sample numbers with power calculations if applicable.
B.SPECIMEN AND DATA CRITERIA: Tables 1and 2 describe in basic terms the data and biospecimens that are available. Use this information to complete Table 3.
C-CFR data and/or biospecimen product price lists, center questionnaires, data dictionaries and summary data are available at
- BIOSPECIMENS(see biospecimen pricing sheet)
DNA from blood
DNA from LCL (lymphoblast)cell-lines
DNA from buccal or saliva cells
DNA from tumor tissue (paraffin embedded)
DNA from normal tissue (paraffin embedded)
DNA from tumor tissue (fresh frozen)
DNA from normal tissue (fresh frozen)
Plasma
Guthrie spot
Tumor tissue from paraffin blocks
Normal tissue from paraffin blocks
Fresh frozen tumor tissue
Fresh frozen normal tissue
Lymphoblast cell line (LCL)(growing culture)
Lymphoblast (LCL)(vial of slow frozen cells)
Digital image of the H&E slide
- DATA
Family history of cancer
Baseline risk factor questionnaire
Follow-up questionnaires
Diet questionnaire
Pathology / clinical data
Molecular data
Other (specify):
- DATA AND SPECIMEN CRITERIA:
needed from CCFR participants (see examples below).
Selection Criteria / Type of data/biospecimen
Include amount of biospecimen to be requested / Number of Participants/
Samples
Example 1: Colorectal cancer cases diagnosed under the age of 35 yrs from population-based ascertainment / Family history of cancer andlymphocyte DNA(200 ng) / 50
Example 2: Female MMR mutation carriers with no previous diagnosis of any cancer. / Baseline epi questionnaire data / 100
Example 3: MYH mutation carriers with a diagnosis of colorectal cancer at any age. / Molecular and
pathologydata / 200
If you are requesting DNA, please answer these questions (Yes/No):
- EBV-transformed cell-lines have been established for some CCFR participants. If blood DNA is not available, is LCL-derived DNA acceptable?
- Saliva was collected from some CCFR participants when blood collection was not possible. If blood DNA is not available, is saliva DNA acceptable?
- DNA will be dispatched based on available resource. If DNA has been depleted additional extraction charges may be required. Will you request samples requiring DNA extraction?
- DNA has been quantitated by spectrophotometry. Will you require quantification by Fluorescent dye (additional costs apply)?
- Requests for DNA concentrations requiring re-concentration may be available for a per sample fee. When not available, the sample volume will be adjusted to meet the total DNA quantity.
Please note: The CCFR operates under a cost recovery system.
The cost of collecting study data and the acquisition and limited processing of biospecimens has mostly been covered by CCFR grants. However, providing data and/or biospecimens to researchers generates additional costs that are not covered by CCFR grants and must be paid for by the researcher requesting the data and/or biospecimens. CCFR centers will prepare and send invoices. All prices are in US dollars. Depending on the center, payment may be requested before data and/or biospecimens are dispatched, at the time of the, and/or following the dispatch.Costs are assessed as follows:
Administrative fees are assessed by each CCFR center providing data and/or biospecimens. These fees cover administrative and programming costs related to obtaining approvalfrom IRB/ethics boards, preparing and negotiating Data Use Agreement(s) and Material Transfer Agreement (s), reviewing study criteria, selecting study samples,preparing sample pull list(s), and preparing dataset(s)for data not available at the Informatics Center. Charges are determined on a site-by-site and case-by-case basis and will not exceed US$2,000 by any one center.
Biospecimen costs are assessed on a per unit basis and cover the cost to pull biospecimens from the repository, extract DNA, quantify DNA, aliquot samples, and prepare the sample dispatch file. Product Pricing Lists and are available at Prices are inflated 3% annually and are subject to change. The prices charged correspond to the date the biospecimens are requested for delivery and all necessary assurance documentation (IRB/ethics, Data Use Agreements, Material Transfer Agreements) have been received,not with the date an application is submitted or approved.
Indirect costs Fred Hutchinson Cancer Research Center must charge indirect costs (indirect rate is 76%).
Packing and shipment costs are for shipping containers, dry ice and freight costs.
III.Agreement for use of epidemiologic, pathologic and outcome data and for biomaterials provided from the Colon Cancer Family Registry
I agree to form a collaboration with the Colon CFR. I agree to assume all risks and responsibilities in connection with the receipt, handling, storage and use of data/biomaterials. I agree that the data/biomaterials to be provided by the NCI Colon CFR will be used for research purposes only and only for the purposes specified in the approved proposal. I will provide documentation of IRB/ethics committee approval that will include my IRB approval number and IRB approval start and end dates. I understand that data and their products biomaterials shall not be sold or used for commercial purposes, nor will I distribute data/biomaterials to third parties without the agreement of the CCFR Principal Investigators.
I further agree to make the study results available to the scientific community by transferring them to the central Colon CFR (CCFR) Informatics Center within 6 months of their publication and to submit progress reports annually until the project is completed. I agree to notify the CCFR of planned publications using CCFR data and to invite CCFR investigators to collaborate on those publications. I will submit publications to the CFR () for administrative review prior to submission to a journal and will acknowledge the contributions of the NCI and CCFR in all publications resulting from the use of these data.
[Recommended wording to the methods or funding acknowledgement section of a resulting publication or presentation is: "Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number UM1CA167551 and through cooperative agreements with the following CCFR centers:: [list those centers that apply]Australasian Colorectal Cancer Family Registry (U01/U24 CA097735), Mayo Clinic Cooperative Family Registry for Colon Cancer Studies (U01/U24 CA074800), Ontario Familial Colorectal Cancer Registry (U01/U24 CA074783), Seattle Colorectal Cancer Family Registry U01/U24 CA074794), Stanford Consortium Colorectal Cancer Family Registry (U01/U24 CA074799) and University of Hawaii Family Registry of Colon Cancer U01/U24 CA074806).]
[For investigators who make use of Colon CFR GWAS data, the acknowledgement should read: “The Colon CFR GWAS data was supported by funding from the National Cancer Institute, National Institutes of Health by grants U01 CA122839 and R01 CA143237 to Graham Casey"].
[For investigators who make use of samples derived from fresh frozen tissue or paraffin-embedded tissue or pathology related variables provided by the Colon CFR, we ask that you please acknowledge: “The Jeremy Jass Memorial Pathology Bank” as the source of your samples and/or data.]
[Also include] “The content of this manuscript does not necessarily reflect the views or policies of the National Cancer Institute or any of the collaborating centers in the Colon Cancer Family Registry (CCFR), nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government or the CCFR.”
The document below formalizes the agreement between the applicant and site(s) tocollaborate.
IV.BY MY SIGNATURE I AGREE TO THE TERMS SET FORTH IN AGREEMENTS III.
Signature of ApplicantTyped Name of Above / Date
Thank you! Please send the completed, signed form to Allyson Templeton ().
CFR Application Form rev Aug 2017
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