Colon CFR Application for Collaboration Process

Introduction to the Colon Cancer Family Registry

The Colon Cancer Family Registry (C-CFR) is an international research infrastructure for investigators interested in conducting population- and clinic-based interdisciplinary studies on the genetic and molecular epidemiology of colorectal cancer and its behavioral implications. The C-CFR was developed by a multidisciplinary, international team of investigators as a consortium of six field centers and an informatics support center (ISC). The six field centers are Lunenfeld-Tanenbaum Research Institute (2013-present)(Cancer Care Ontario (1997-2013), the Fred Hutchinson Cancer Research Center, the Mayo Clinic, the University of Hawaii, the University of Southern California, and the University of Melbourne. The ISC is housed at University of Melbourne, Australia.

A central goal of the C-CFR is the translation of this research to the clinical and prevention setting for the benefit of registry participants and the general public. The C-CFR has information and biospecimens contributed by more than 14,300 families across the spectrum of risk for colon cancer and from population-based, spouse or relative controls.

Of particular interest are:

  • Identification and characterization of cancer susceptibility genes
  • Definition of gene-gene and gene-environment interactions in cancer etiology
  • Translational, preventive, and behavioral implications of research findings

Special features include:

  • Population-based and clinic-based ascertainment
  • Systematic collection of validated family history
  • Epidemiologic risk factor data
  • Clinical and treatment data
  • Follow-up data
  • Biospecimens (including tumor sections and Epstein-Barr virus (EBV)-transformed cell lines)
  • Ongoing molecular characterization of the participating families

The Colon-CFR Site Principal Investigators

Each CFR site has a designated PI and some also have a Co-PI. After establishing which sites they are interested in collaborating with (i.e., receiving resources from), applicants should contact the PIs and/or Co-PIs of those sites. The site PIs are the investigators with the most intimate knowledge of the data and materials collected for the CFR at their institutions and can provide valuable insights relevant to most CFR projects. These interactions also provide an opportunity to foster truly collaborative studies between external investigators and CFR personnel. The PIs and Co-PIs of each site are listed in Table 1 below.

Table 1. Contact Information for Colon-CFR Site Principal Investigators

Australian Colorectal Cancer Family Registry
Mark Jenkins, Ph.D. / PI /
Daniel Buchanan, Ph.D. / Co-PI /
Hawaii Family Registry of Colon Cancer
Loic Le Marchand, M.D., Ph.D. / PI /
Mayo Colorectal Cancer Family Registry
Noralane Lindor, M.D. / PI /
Stephen Thibodeau, Ph.D. / Co-PI /
Ontario Familial Colorectal Cancer Registry
Steve Gallinger, M.D. / PI /
Michelle Cotterchio, Ph.D. / Co-PI /
Seattle Familial Colorectal Cancer Registry
Polly Newcomb, Ph.D. / PI /
Stanford/University of Southern California Consortium
Robert Haile, Dr.P.H. / PI /
Graham Casey, Ph.D. / Co-PI /

CCFR Consortium Coordinator: Allyson Templeton ()

Colon-CFR Application and Review Process

The resources collected by the C-CFR are open to the scientific and medical community for collaborative research projects. To date more than 250 collaborative studies have been approved, resulting in more than 400 manuscripts published on projects that utilized the C-CFR research infrastructure. The application and review process is described below.

Investigators interested in pursuing collaborative research projects using Cancer Family Registries (CFR) resources must submit an Application for Collaborationfor access to the available data and biological materials. Applicants are encouraged to review the list of approved applications for potential overlap with their concept. Submitted applications are reviewed with careful consideration given to their scientific merit, their overlap with ongoing CFR studies, and the impact of the proposed study on the inventory of biological materials. The reviews take approximately 6 weeks from submission to final notification.

The Steering Committee Review—The Consortium Coordinator distributes applications to the SC for review and comment. Applications requesting access to biological materials are distributed to the chairperson of the Biospecimen Working Group (BWG) prior to distribution to the SC. Other CFR investigators or committees may be asked to review specific applications on an ad hoc basis if the SC chairperson deems their expertise necessary to evaluate an application.

The specified committees review and comment on the proposal. The issues they carefully consider include the following:

  • The availability of requested resources
  • The impact of the biospecimen requests on the inventory of resources
  • Feasibility of the project considering available resources
  • Potential overlap with ongoing CFR projects

During the application review the applicant may be contacted by members of the reviewing committee(s) and/or the Consortium Coordinator requesting clarification of specific issues.

The Principal Investigatorfrom each CCFR center named in the application decides whether they wish to collaborate on the proposed study and share their data or not. Some may choose to opt in while others may opt out.

Once all Principal Investigators have reviewed the application and decided whether they wished to collaborate on the proposed study, the Consortium Coordinator notifies the applicant by e-mail. If one or more Principal Investigator agrees to collaborate on the proposed study, the Consortium Coordinator provides the applicant with a letter of collaboration and instructions for moving forward. Briefly, applicants with approved applications must provide the Coordinator with documentation of IRB approval for the proposed study using CFR data/biospecimens (or determination of IRB/ethics exemption). The University of Melbourne will initiate a Data Use Agreement with the applicant’s institution. For proposals using CCFR biospecimens, each center providing biospecimens will initiate a center-specific Material Transfer Agreement with the applicant institution. Applicants then complete a Data Request Form that is used by the Informatics Center in preparing the dataset and by the field centers for dispatching biospecimens.

There are expenses associated with sample selection, pulling of samples, IRB approval, Material Transfer Agreement preparation, restocking samples, etc. that will need to be incurred by the applicant. Price lists can be found at Centers sharing data and/or biospecimens will invoice the applicant. As a rule, payment is expected before data and/or biospecimens are dispatched.

Applicants must:

1.Agree to assume all risks and responsibilities in connection with the receipt, handling, storage and use of CCFR data/biomaterials and to restrict their use to the purposes specified in the approved proposal;

2.Agree not to sell or use for commercial purposes CCFR data and their products biomaterials

3.Agree not to distribute CCFR data and/or biospecimens to third parties without the agreement of the CCFR Principal Investigators;

4.Make their study results available to the scientific community by transferring them to the central Colon CFR (CCFR) Informatics Center within 6 months of their publication;

5.Submit a progress report annually until the project is completed;

6.Agree to notify the CCFR of planned publications using CCFR data and to invite CCFR investigators to collaborate on those publications according to the CCFR Policy for Publications.

Amendments to Ongoing Colon-CFR Projects

Most modifications to approved, ongoing C-CFR projects can be made through the submission of an amendment. Amendments undergo scientific review and approval. Typically, modifications that can be implemented through the submission of an amendment include:

  • Replacement of the lead PI
  • Addition of site collaborations and/or key personnel
  • Requests for additional biospecimen materials
  • Requests for additional data resources
  • Addition of new study populations needed to increase statistical power
  • Significant changes in or additions to methodology (e.g., a new micro-array platform)
  • Study of additional genes in molecular pathways described in the original application
  • The study of additional environmental factors
  • Addition of new, related specific aims

Modifications deemed by the CCFR Principal Investigators to be substantially dissimilar to the original project may require submission of a new application. Examples include (but are not limited to):

  • The addition of new specific aims constituting a new area of study
  • The study of genes in molecular pathways not described in the original application.

The amendment form is a short, 2-page document describing the changes to the original application as well as any additional resources being requested. Amendment forms can be located at Completed Amendments should be submitted to the CCFR Consortium Coordinator. Amendments are reviewed by the Principal Investigators using a similar process and evaluation criteria as a new application. It generally takes about 5 weeks to process an amendment from submission to final notification.