Opportunity Information: Apply for RFA CA 14 010

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Molecular and Cellular Characterization of Screen Detected Lesions (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.396 Cancer Biology Research.
  • This funding opportunity was created on Jun 6, 2014 and posted on Jun 6, 2014.
  • Applicants must submit their applications by Sep 17, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $4,500,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $500,000.00 in funding.
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Molecular and Cellular Characterization of Screen Detected Lesions (U01) funding opportunity (RFA-CA-14-010) is a National Cancer Institute (NCI), National Institutes of Health (NIH) initiative designed to improve how researchers and clinicians understand cancers found through screening. The central idea is that not all lesions detected early through screening behave the same way: some may remain indolent for long periods, while others may progress rapidly. This FOA supports research aimed at deeply characterizing the molecular features, cellular composition, and local tissue microenvironment of early, screen-detected lesions and comparing them against cancers that appear between screening visits (interval cancers) or are found after symptoms develop (symptom-detected cancers). The overall purpose is to identify biological differences that help explain why some early lesions become dangerous while others may not, and to ultimately improve prediction of lesion outcomes and guide better clinical decisions.

The opportunity specifically calls for independent, multidisciplinary research teams to conduct comprehensive analyses of tumor tissue, individual cell populations, and microenvironmental components. It emphasizes studying both molecular phenotypes (for example, genomic, epigenomic, transcriptomic, proteomic, or other molecular signatures) and cellular phenotypes (such as cell states, immune infiltration patterns, stromal interactions, and spatial organization). A key theme is the use of enabling approaches and advanced technologies that can capture fine-grained detail about early lesions. While the FOA does not limit applicants to any single method, it encourages approaches capable of resolving complexity in early disease, including questions about whether lesion behavior is largely predictable based on measurable biology or whether progression involves more stochastic, chance-driven events. The expectation is that these richer datasets can support more accurate models for forecasting the likely fate of early lesions.

Research under this FOA is organized around several major tumor sites of interest: breast, prostate, lung, melanoma, and pancreas. Applicants may focus on one or more of these sites, and each team can pursue one or more aspects of molecular and cellular analysis. During final awards, NCI indicated it would attempt, if feasible, to fund a set of projects that collectively covers most of the specified tumor sites, supporting a broader, cross-cancer understanding of screening-detected disease and interval cancers. This cross-site perspective matters because screening and early detection challenges differ by organ system, yet there may be shared biological principles that explain aggressiveness, dormancy, immune escape, or microenvironmental support of tumor growth.

A defining feature of this award is that it is a cooperative agreement (U01), which typically means NIH staff will have substantial involvement in coordinating or guiding certain aspects of the program compared with a standard investigator-initiated grant. The FOA anticipates that funded teams will not operate in isolation. Instead, awardees are expected to participate in a collaborative Consortium, sharing data and results openly within the group and developing trans-Consortium projects that leverage combined expertise and technology across teams. In addition to each team pursuing its own scientific aims, the Consortium is expected to undertake a major shared activity: establishing an annotated biospecimen repository containing screen-detected lesions and interval cancers. The repository concept signals that the program is not just funding one-off analyses, but is also investing in a structured resource that can enable harmonized comparisons, future studies, and possibly standardized annotation and quality practices to make samples broadly useful for integrated analyses.

From an operational standpoint, the FOA was posted June 6, 2014, with an original and current closing date of September 17, 2014, and an archive date of October 18, 2014. The estimated total funding listed is $4.5 million, with an award ceiling of $500,000. Cost sharing or matching is not required. The activity categories and CFDA numbers linked to the program reflect its alignment with cancer causes and prevention research (93.393), cancer detection and diagnosis research (93.394), and cancer biology research (93.396), reinforcing that the work is intended to connect basic biology to clinically meaningful early detection and risk stratification questions.

Eligibility is broad across common U.S.-based research and academic entities, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits), state governments, small businesses, and for-profit organizations other than small businesses, with additional eligible applicants including several types of minority-serving institutions and eligible federal agencies. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined in NIH policy are allowed, which typically means certain international elements can participate under defined conditions while the applicant organization remains U.S.-based.

Taken together, this FOA is aimed at building a coordinated research effort that goes beyond traditional tumor profiling by tightly focusing on the biology of lesions found through screening and by directly comparing them to clinically emerging cancers that elude or arise between screenings. By pairing advanced molecular and cellular characterization with a collaborative Consortium structure and a shared, annotated biospecimen repository, the program is structured to produce both immediate scientific findings and longer-term community resources. The intended payoff is clearer biological criteria for distinguishing early lesions likely to progress from those less likely to cause harm, leading to better prediction, improved patient management, and potentially reduced overtreatment while still catching truly dangerous disease early.

Frequently Asked Questions (FAQs)

What is the Molecular and Cellular Characterization of Screen Detected Lesions (U01) opportunity?

This funding opportunity (RFA-CA-14-010) is a National Cancer Institute (NCI), National Institutes of Health (NIH) initiative that supports research to better understand cancers and lesions found through screening. It focuses on detailed molecular and cellular characterization of early, screen-detected lesions and comparisons to cancers detected between screening visits (interval cancers) or after symptoms develop (symptom-detected cancers).

What is the main purpose of this FOA?

The purpose is to identify biological differences that help explain why some screen-detected lesions remain indolent while others progress rapidly, and to use that knowledge to improve prediction of lesion outcomes and guide better clinical decision-making.

Why does the FOA emphasize screen-detected lesions?

The FOA is built around the idea that lesions detected early through screening do not all behave the same way. Some may stay stable for long periods, while others may become dangerous. Understanding these differences at the molecular, cellular, and microenvironment levels is central to improving early detection and reducing unnecessary treatment while still identifying aggressive disease early.

What types of cancers or tumor sites are included?

The FOA highlights several major tumor sites of interest: breast, prostate, lung, melanoma, and pancreas. Applicants may focus on one or more of these tumor sites.

Do applicants have to study all the listed tumor sites?

No. Applicants may focus on one or more of the specified tumor sites (breast, prostate, lung, melanoma, and/or pancreas). NCI indicated it would attempt, if feasible, to fund a set of projects that collectively covers most of the specified sites.

What kinds of comparisons does the FOA encourage?

The FOA encourages comparing early, screen-detected lesions against interval cancers (those appearing between screening visits) and symptom-detected cancers (those found after symptoms develop). These comparisons are intended to reveal biological differences linked to aggressiveness, dormancy, immune escape, or microenvironmental support of tumor growth.

What types of analyses are expected under this program?

The FOA calls for comprehensive analyses of tumor tissue, individual cell populations, and microenvironmental components. It emphasizes both molecular phenotypes (for example, genomic, epigenomic, transcriptomic, proteomic, or other molecular signatures) and cellular phenotypes (such as cell states, immune infiltration patterns, stromal interactions, and spatial organization).

Are specific technologies or methods required?

No single method is required. The FOA encourages enabling approaches and advanced technologies capable of capturing fine-grained detail about early lesions and resolving biological complexity in early disease.

What scientific questions is this FOA trying to address?

A key theme is determining whether lesion behavior is largely predictable based on measurable biology or whether progression involves more stochastic (chance-driven) events. The FOA expects richer datasets to support more accurate models for forecasting the likely fate of early lesions.

What does the U01 activity code mean for this opportunity?

This is a cooperative agreement (U01). In general, that means NIH staff are expected to have substantial involvement in coordinating or guiding certain program aspects compared with a standard investigator-initiated grant, and awardees are expected to work in a coordinated way rather than operating entirely independently.

Is this opportunity structured as a Consortium?

Yes. The FOA anticipates that funded teams will participate in a collaborative Consortium, share data and results openly within the group, and develop trans-Consortium projects that leverage combined expertise and technologies.

What shared resource is the Consortium expected to build?

The Consortium is expected to establish an annotated biospecimen repository containing screen-detected lesions and interval cancers. This is intended to support harmonized comparisons and enable future studies using standardized annotation and quality practices.

Does the FOA only fund one-off profiling studies?

No. In addition to supporting individual team research aims, the FOA signals investment in a structured, shared resource (the annotated biospecimen repository) and collaborative activities that can support integrated analyses and longer-term community value.

Who is the sponsoring agency?

The sponsoring agency is the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).

What is the total estimated funding for the program?

The estimated total funding listed is $4.5 million.

What is the award ceiling?

The award ceiling listed is $500,000.

Is cost sharing or matching required?

No. The FOA states that cost sharing or matching is not required.

When was the FOA posted and what were the key dates?

The FOA was posted on June 6, 2014. The original and current closing date was September 17, 2014. The archive date was October 18, 2014.

Is this funding opportunity still open?

Based on the provided dates, the FOA has a closing date of September 17, 2014 and an archive date of October 18, 2014, indicating it is not currently open.

What kinds of organizations are eligible to apply?

Eligibility is broad across U.S.-based entities, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits), state governments, small businesses, and for-profit organizations other than small businesses. Several types of minority-serving institutions and eligible federal agencies are also included as eligible applicants.

Are foreign institutions eligible to apply?

No. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.

Can international partners be involved at all?

Yes, under certain conditions. While foreign institutions and non-U.S. components are not eligible to apply, foreign components (as defined in NIH policy) are allowed, meaning certain international elements can participate while the applicant organization remains U.S.-based.

Which CFDA program areas are associated with this FOA?

The CFDA numbers referenced are 93.393 (cancer causes and prevention research), 93.394 (cancer detection and diagnosis research), and 93.396 (cancer biology research).

What is the expected impact of the research supported by this FOA?

The intended payoff is clearer biological criteria for distinguishing early lesions likely to progress from those less likely to cause harm, leading to better prediction, improved patient management, and potentially reduced overtreatment while still catching truly dangerous disease early.

Does the FOA connect basic biology to clinical decision-making?

Yes. The FOA emphasizes understanding molecular and cellular features of early lesions in ways that can improve outcome prediction and guide better clinical decisions related to screening-detected disease.

Does the FOA encourage cross-cancer learning?

Yes. NCI described a goal of funding projects that collectively cover most of the specified tumor sites, supporting a broader, cross-cancer understanding of screening-detected lesions and interval cancers, and potentially identifying shared biological principles across organs.

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Previous opportunity: Molecular and Cellular Characterization of Screen Detected Lesions Coordinating Center and Data Management Group (U01)

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