ICGCmed Request for Application Template
Over the summer ICGCmed leaders will be developing a template for requests for applications (RFAs). Funding agencies have expressed interest in seeing a model of elements to include in their RFAs. ICGCmed scientific leaders will provide more specific guidelines for funding agencies to include in the RFA. This fall, ICGCmed leaders hope to announce more funders who have decided to participate in the project.
Due date: Day Month YYYY
Introduction
The International Cancer Genome Consortium for Medicine (ICGCmed) is a new phase in the evolution of ICGC that will broaden links between genomics and clinical information, including treatment, response, outcomes and other health data. This new international collaborative project will build upon the vast database of genomic discoveries made by the ICGC, which, since its launch in 2008, is on target to meet its 10-year goal of characterizing 25,000 different cancer genomes across 50 different tumor types while making these data freely available to qualified researchers around the world.
The aim of ICGCmed is to sequence 200,000 tumor genomes and their matched normal genomes by 2025. This is eight times the number under the first phase of ICGC. In addition to providing the required molecular data, participating projects will be required to provide much deeper annotation with high quality clinical information.
By linking genomic data to clinical history, treatment response, and outcomes, ICGCmed is expected to accelerate the movement of genomic information into clinical practice to guide prevention, allow for early detection, promote precise diagnosis and prognosis, and to help match patients’ disease to the most effective combinations of therapy. In addition, ICGCmed is expected to help guide the development of new medicines and treatment approaches by nominating novel genes or pathways for drug development, helping suggest new ways to avoid the development of resistance to treatment, and clarifying why patients differ in their responses.
ICGCmed research will work across a broad spectrum of disease types, from precancerous lesions and early tumors through to metastases, across a broad range of tissue types. Many ICGCmed analyses are expected to be based in the context of prospective or retrospective clinical trials with extensive biorepositories in order to maximize the clinical utility of findings. However, the only determining criteria for inclusion in ICGCmed are whether a study provides the required molecular and clinical data, and ethical oversight.
This RFA seeks expressions of interest from researchers wishing to collect and characterize patient samples and to perform genome sequencing. [Optional: A pending companion RFA will seek expressions of interest from computational groups who wish to support the project by providing data processing and/or analytic services.]
COUNTRY/JURISDICTION or LOCAL INSTITUTION is a member of the ICGCmed through NAME OF FUNDING AGENCY. The NAME OF FUNDING AGENCY will support a(n) Country/Jurisdiction or Institute contribution to the ICGCmed.
NAME OF FUNDING AGENCY is seeking expressions of interest
Expressions of interest are invited from research groups or consortia of research groups to undertake the Country/Jurisdiction part of the ICGCmed initiative.
The final decision on supported studies will be based on expert peer review of the bids received and the advice of the Funding Agency Committee/Board.
The expression of interest should be no more than 10 pages overall excluding appendices, using 12 point font and single spacing throughout. The following items should be addressed in the expression of interest:
1 The number of patients to be included in the project, the origin of the cohorts studied and the tumor type(s) or subtype(s) to be analyzed
2 Argument for why work on the proposed tumor or tumors should represent a major contribution from Country/Jurisdiction to the ICGCmed initiative (no more than 2 pages). Applicants should include the material in Appendix 1 as an addendum to their expression of interest
3 Brief curriculum vitae details of the researchers (append full CV of the project leader) and details of any research groups involved
4 Brief details of clinicians and clinical centers involved in obtaining the tumor tissues and clinical information
5 Details on how ethical issues will be addressed
6 Description of the scientific and technical ability to undertake the required analyses (no more than 5 pages), with particular reference to the matters detailed in the ICGCmed white paper including clinical datasets and type of studies, such as prospective or retrospective (
7 A detailed 5-year budget for the full spectrum of work required by the ICGCmed
Full details of the ICGCmed are available through their website
Potential applicants are strongly advised to be thoroughly familiar with the requirements of the ICGCmed and to take note of the scale of work required in relation to the selected cancer(s).
The FUNDING AGENCY may seek further information from applicants prior to making a decision.
Applicants should note that the FUNDING AGENCY will commit to support studies of at least 4,000 patients which may be in one or more cohort and represent one or several tumor types. The FUNDING AGENCY urges research groups to form consortia rather than competing bids to reach these numbers.
The FUNDING AGENCY may consider providing limited support for Country’s cancer researchers to participate in smaller studies of tumors being addressed by international groups, depending on resources being available.
Timeline
Expressions of interest are due with the FUNDING AGENCY by close of business Day NN Month YYYY.
Applications should be forwarded in electronic form (preferably PDF) to e-mail address (link sends e-mail).
Further information can be obtained from:
Dr. First Name Last Name
tel.
email address
Background
The International Cancer Genome Consortium (ICGC) has produced insights into the biology of cancer, as well as discovered many correlates of clinical importance. These accomplishments include uncovering novel tumor signatures; revealing oncogenic processes; identifying driver mutations and their pathways; supporting the integration of epigenomes and genomes; and determining the impact of germline alterations, cancer-causing pathogens, and mutations in regulatory regions.
However, most ICGC projects were built on biobanked historical cancer specimens rather than linked to clinical studies including information about patient responses to therapies. In general, the ICGC projects were not structured to provide the information needed to guide clinical decision-making. ICGCmed will now build on the ICGC foundation and coordinate an international-scale research effort to understand the genomic, transcriptomic, and epigenetic changes involved in a wide variety of cancers, from the most frequent tumors to rare diseases, with linkage to carefully-gathered information on disease history, family history, environmental and behavior habits, response to treatments, and other clinical data. This information will lead to better ways of diagnosing, treating, and preventing cancer.
Studies to be carried out
The ICGCmed leaders have published detailed requirements for the work to be carried out (ICGCmed White Paper at
In summary, each tumor type or subtype is expected to include the full range of somatic mutations including single base substitutions, insertions, deletions, copy number changes, translocations, and other chromosomal rearrangements. A minimal set of genomic tests should include exome sequencing and RNAseq. In addition, research groups or consortia are encouraged to perform complementary analyses on the collected samples, particularly whole genome sequencing, and analyses of DNA methylation and RNA expression. Additional analyses are outside the scope of the ICGCmed but are encouraged.
Consent issues
The ICGC will apply common standards for informed consent and ethical oversight, consistent with each country’s requirements. In Country, the Funding Agency expects participants to fully adhere to STANDARDS (e.g.,in Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans). This will ensure that Country.Jurisdiction conforms with the ICGCmed’s policies, which state that cancer patients enrolled in an ICGCmed-related study should be informed (or have been informed) that their participation is voluntary, that their clinical care will not be affected by their participation and that data obtained from analyses using their samples will be made available to the international research community.
Appendix:ICGCmed White Paper
The mandatory elements listed in the Appendix of the ICGCmed White Paper constitute a minimal set of information. These might need to be expanded for a given tumor entity or scientific questions of a trial. All samples will have to be reviewed by two or more reference pathologists. This assessment will need to be performed on stained sections of the same block of tissue from which biomolecules will be purified. Histological examination must be documented and digital histology images must be made available to those studying the given samples.
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