Cancer Epidemiology Cohorts: Core Infrastructure and Methodological Research


Importance of Cancer Epidemiology Cohorts

Cancer epidemiology cohorts have helped advance the understanding of the complex etiology of cancer and provided fundamental insights into key environmental, lifestyle, and genetic determinants of this disease. Findings from these cohorts are also critical for cancer risk prediction analyses and models. The findings may also serve as a basis for risk prediction models, cancer control trials, intervention strategies, and/or the design and testing of many preventive and therapeutic interventions. Large biorepositories established by cohort studies already support genomic and epigenetic studies, and are beginning to support proteomic and metabolomics studies.

High quality, population-based cohort studies can provide a foundational framework for epidemiology across the cancer continuum from etiology to survivorship. Successful cohorts of the 21st century will need to be maximally suited to participate in a large, worldwide network of cohorts to achieve the statistical power needed to address increasingly complex scientific questions, and accrue large and diverse population samples.

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NCI Support of Cancer Epidemiology Cohorts

The National Cancer Institute (NCI) recognizes that cancer epidemiology cohorts are valuable resources that benefit the entire cancer research community. The Epidemiology and Genomics Research Program (EGRP) in NCI's Division of Cancer Control and Population Sciences (DCCPS) has long been a supporter of cancer epidemiology cohorts.

NCI published a notice in the NIH Guide for Grants and Contracts of a Funding Opportunity Announcement (FOA) to provide support for core functions of cancer epidemiology cohorts, PAR-14-160, Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01)External Web Site Policy. The ultimate goal of this Program Announcement with Review (PAR) is to consolidate all infrastructure components of a given NCI-supported cancer epidemiology cohort under a single cooperative agreement and enable NCI to more efficiently and effectively manage NCI's portfolio of cancer epidemiology cohorts and foster data sharing and collaboration. Note: Research projects relying on a given cohort's infrastructure will continue to be supported separately through investigator-initiated grant mechanisms (R01, P01, etc.).

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Frequently Asked Questions

  1. What is the purpose of this FOA?
  2. What mechanism of support will this FOA utilize?
  3. How much funding is available through this FOA?
  4. What functions related to cancer epidemiology cohorts will be supported under this PAR?
  5. What funding mechanisms are available to support scientific, hypothesis-driven research utilizing cancer epidemiology cohorts?
  6. Who is eligible to apply for support through this FOA?
  7. Study participants in my cohort were selected from individuals with a particular occupation, but the research is not focused specifically on potential occupational factors and cancer risk. May I still apply for this funding?
  8. Are there specific types of new cancer epidemiology cohorts that NCI encourages investigators to submit new funding applications in response to this FOA?
  9. I am a cancer epidemiologist with a research institution outside the United States. Can my organization submit an application for funding in response to this FOA?
  10. Who is required to submit an application in response to this FOA?
  11. I have a cancer epidemiology cohort that has been previously funded, but not through EGRP. Am I eligible to submit an application in response to this FOA?
  12. What are some of the key elements that must be included in an application submitted in response to this FOA?
  13. Are there any specific processes or timelines I need to be aware of when preparing to submit an application in response to this FOA?
  14. Is a Letter of Intent required?
  15. The budget for my application is not likely to exceed $500,000 in direct costs in any one year. Do I still need to request approval from the Division of Cancer Control and Population Sciences to submit an application in response to this FOA?
  16. How will applications submitted in response to this PAR be evaluated?
  17. What are the key terms of this FOA?

1. What is the purpose of this FOA?

This Funding Opportunity Announcement (FOA) invites grant applications for targeted infrastructure support of the core functions of cancer epidemiology cohorts (CECs) and methodological research. Through this FOA, the NCI will support infrastructure and core functions for existing or new CECs. This FOA will also lead to support of core functions for CECs currently funded through other grant mechanisms by EGRP and other components of DCCPS at the NCI. See Question #4 for examples of core functions and methodological research.

NOTE: Research projects relying on cancer epidemiology cohort infrastructure are NOT appropriate for this FOA. Such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01 and P01 projects).

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2. What mechanism of support will this FOA utilize?

This FOA will utilize a Cooperative Agreement (U01) mechanism.

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3. How much funding is available through this FOA?

Because of the nature and scope of the proposed core functions and research both will vary from application to application. It is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds.

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4. What functions related to cancer epidemiology cohorts will be supported under this PAR?

Specific core functions that can be supported for existing or newly proposed cohorts include, but are not limited to:

  • Ongoing or new accrual of the target population, and enrollment of special and/or under-represented populations in the sampling frame;
  • Follow-up (active and passive) of enrolled participants;
  • Systematic, high-throughput assessment of genetic or other biological markers when required to interpret new research findings or when these markers are not already available on all relevant cohort study subjects (e.g., tumor hormone receptor status);
  • Validation, quality control, standardization, harmonization, and/or calibration of data across cohorts;
  • Biospecimen collection and management, with emphasis on blood and tissue collection;
  • Development of bioinformatics and big data approaches for managing, storing, integrating, and sharing information from multiple levels (from ecologic to molecular);
  • Data management and data sharing activities, and administrative and communication tasks; and
  • Utilization of modern approaches, such as mobile web-based technologies for data collection and communication with participants is strongly encouraged.

Methodologic research may include, but is not limited to, research investigating the following:

  • Improved approaches to the systematic, high-throughput assessment of genetic or other biological markers;
  • Validation of exposures and health outcomes, for example, the quality of self-reported data versus medical record information, or assessment of how well a biomarker measured through non-invasive means compares to that measured in an appropriate target tissue;
  • Development and improvement of quality control and quality assurance activities related to laboratory work, data use, biospecimens, etc.;
  • Methods for biospecimen collection and management; and
  • Virtual tissue repositories with metadata about available tissues across cohorts and connections to pathologic tissue image libraries.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description; and Section IVExternal Web Site Policy, Application and Submission Information.

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5. What funding mechanisms are available to support scientific, hypothesis-driven research utilizing cancer epidemiology cohorts?

Research projects relying on cancer epidemiology cohort infrastructure are NOT appropriate for this FOA. Such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01 and P01 projects).

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6. Who is eligible to apply for support through this FOA?

Support is envisioned for three types of cancer epidemiology cohorts through this FOA:

  • Cancer epidemiology cohorts with at least 10,000 study participants that are capable of supporting studies to examine the effects of multiple exposures and study participants’ characteristics on the risk of multiple types of cancers and cancer mortality;
  • Cohorts of cancer patients/survivors of at least 5,000 participants (across multiple cancer sites) or at least 2,000 participants (diagnosed with the same or narrowly related cancer sites) to support research addressing determinants of cancer progression, recurrence, mortality, incidence, and other cancer/health-related outcomes; and
  • Familial cohorts of at least 5,000 participants (across multiple cancer sites) or at least 2,000 participants (diagnosed with the same or narrowly related cancer sites) to support research on determinants of familial cancer risk, progression, recurrence, mortality, and other cancer/health-related outcomes.

Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., "occupational cohorts") may be appropriate for this FOA, but only if they were established to examine a broad range of exposures potentially experienced by the general public and/or genomic factors affecting cancer risk or outcomes after cancer diagnosis. Cancer surveillance activities and development and maintenance of registries of persons with particular characteristics that do not address identification of factors affecting risk are not appropriate for this FOA.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description.

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7. Study participants in my cohort were selected from individuals with a particular occupation, but the research is not focused specifically on potential occupational factors and cancer risk. May I still apply for this funding?

Yes. Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., “occupational cohorts”) may be appropriate for this FOA, but only if they were established to examine a broad range of exposures potentially experienced by the general public and/or genomic factors affecting cancer risk outcomes after cancer diagnosis. Cohorts focusing primarily on cancer risks associated with one exposure limited to the workplace are not appropriate for this FOA.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description.

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8. Are there specific types of new cancer epidemiology cohorts that NCI encourages investigators to submit new funding applications in response to this FOA?

NCI is not specifically requesting any particular types of cancer epidemiology cohorts at this time. This FOA is primarily intended to enable NCI to better manage its current grant portfolio of cancer epidemiology cohorts. NCI has supported many investigator-initiated applications that involve the establishment or continuation of cancer epidemiology cohorts and plans to continue to support meritorious applications that are consistent with NCI’s priorities and budget.

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9. I am a cancer epidemiologist with a research institution outside the United States. Can my organization submit an application for funding in response to this FOA?

Yes. Applications may be submitted by foreign organizations. Proposed research should provide special opportunities for furthering programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing resources. NIH policies concerning grants to foreign organizations can be found in the NIH Grants Policy StatementExternal Web Site Policy.

For more details, see Part II of the FOA, specifically Section IIIExternal Web Site Policy, Eligibility Information, 1. Eligible Applicants and Section IVExternal Web Site Policy, Application and Submission Information, 2. Content and Form of Application Submission.

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10. Who is required to submit an application in response to this FOA?

This FOA must be used for all requests for support to continue existing cancer epidemiology cohorts or to establish new ones.

The transition to the consolidated infrastructure support may be initiated, for example, when a grant that contains core infrastructure components becomes eligible for renewal. 

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description.

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11. I have a cancer epidemiology cohort that has been previously funded, but not through EGRP. Am I eligible to submit an application in response to this FOA?

Yes, if the cohort meets the criteria described in Question #6 and in the FOA. Potential applicants are strongly encouraged to contact Dr. Daniela Seminara (seminard@mail.nih.gov) several months before the anticipated submission date (4-5 months is a good rule of thumb) to determine whether the proposal is appropriate for this FOA and to discuss the pre-submission process and timeline. See Questions #14 and #15 for more information about processes and timelines to be aware of when preparing to submit an application in response to this FOA.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description; Section IVExternal Web Site Policy, Application and Submission Information; and Section VIIExternal Web Site Policy, Agency Contacts.

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12. What are some of the key elements that must be included in an application submitted in response to this FOA?

All application instructions outlined in the SF424 Application Instructions are to be followed, with the additional requirements:

  • SF 424(R&R) Other Project Information
    • Each application must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication.
  • Research Strategy
    • Program (Cohort) Overview is limited to 12 pages.
      • Background and Experience
      • Overall description and summary purpose of proposed cohort
      • Progress (for existing cohorts only)
    • Infrastructure Design and Methods is limited to 12 pages.
      • Cohort Infrastructure
      • Core Infrastructure Activities
      • Organization Structure
      • Broad Research Agenda
    • Leadership and Administrative Structure is limited to 6 pages.
      • The experience with cancer epidemiology cohorts (CEC) for proposed PD/PI(s) must be described, specifically documenting their respective abilities to organize and manage a CEC and related activities.
  • Resource sharing plan (i.e., data sharing plan).

More details about the application process are available in Part II of the FOA, Section IVExternal Web Site Policy, Application and Submission Information.

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13. Are there any specific processes or timelines I need to be aware of when preparing to submit an application in response to this FOA?

Potential applicants are strongly encouraged to consult with EGRP to clarify the expectations, requirements, and limitations of infrastructure support through this FOA. Ideally, new cohorts should consult with EGRP four months prior to the submission of their application, and existing cohorts should consult with EGRP at least eight weeks prior to submission.

Prospective applicants are asked to submit a Letter of Intent 30 days before the due date that includes the following information:

  • Descriptive title of proposed research;
  • Name(s), address(es), and telephone number(s) of the Program Director(s)/Principal Investigator(s);
  • Names of other key personnel;
  • Participating institution(s); and
  • Number and title of this FOA.

For more details, see Part II of the FOA, specifically Section IVExternal Web Site Policy, Application and Submission Information; Section VIIExternal Web Site Policy, Agency Contacts; and view more information about EGRP’s procedure for submitting an awaiting receipt of application (ARA).

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14. Is a Letter of Intent required?

No; however, EGRP strongly encourages applicants to submit a Letter of Intent. While a Letter of Intent is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review.

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15. The budget for my application is not likely to exceed $500,000 in direct costs in any one year. Do I still need to request approval from the Division of Cancer Control and Population Sciences to submit an application in response to this FOA?

No. Only applicants requesting $500,000 or more in subtotal direct costs in any year are required to request prior approval to submit an application through this FOA. It is strongly recommended that the applicant submit a letter of intent 30 days prior to the anticipated receipt date.

For more details, see Part II of the FOA, specifically Section IVExternal Web Site Policy, Application and Submission Information; Section VIIExternal Web Site Policy, Agency Contacts; and view more information about EGRP’s procedure for submitting an awaiting receipt of application (ARA).

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16. How will applications submitted in response to this PAR be evaluated?

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  • Significance,
  • Investigator(s),
  • Innovation,
  • Approach, and
  • Environment.

For more detailed information about the evaluation criteria, see Part II of the FOA, specifically Section VExternal Web Site Policy, Application Review Information.

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17. What are the key terms of this FOA?

Awardees will be expected to evaluate and document compliance NCI's Best Practices for Biospecimen Resources for collection, processing, and storage of future and past biospecimens.

Awardees will be required to explore, with NCI staff and other awardees of this FOA, the feasibility of pooling exposure data across cohorts. Awardees will be required to provide descriptive data and metadata on cohort characteristics through a pooled NCI database.

Awardees are encouraged to register the cohort through ClinicalTrials.gov.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. For more detailed information, see Part II of the FOA, specifically Section VExternal Web Site Policy, Application Review Information.

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