Notice of Intent to Publish a Funding Opportunity Announcement for Translational and Basic Science Research in Early Lesions (TBEL) (U54 Clinical Trial Not Allowed)
Notice Number:

Key Dates

Release Date:
April 21, 2021
Estimated Publication Date of Funding Opportunity Announcement:
June 01, 2021
First Estimated Application Due Date:
October 01, 2021
Earliest Estimated Award Date:
July 01, 2022
Earliest Estimated Start Date:
August 01, 2022
Related Announcements

NOT-CA-21-061 - Notice of Intent to Publish a Funding Opportunity Announcement for Coordinating and Data Management Center for Translational and Basic Science Research in Early Lesions (TBEL) (U24 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)


The National Cancer Institute (NCI) intends to publish a Funding Opportunity Announcement (FOA) as a Request for Applications (RFA) for Translational and Basic Science Research in Early Lesions (TBEL) Centers (U54). The TBEL program aims to integrate basic and translational cancer research concepts to examine the direct causal relationships and interactions of an early lesion, its microenvironment and host-systemic factors as “co-organizers” of tumor initiation (or suppression) and malignant progression. The ultimate goals of the TBEL program are to further understand the biological and pathophysiological mechanisms driving or restraining precancers and early cancers and facilitate biology-backed precision prevention approaches.

Each TBEL Center shall have a unique thematic focus and be structured to test hypotheses that bridge basic and translational research in a synergistic and iterative fashion. Collectively, TBEL Centers will operate as a network that will inform future, rationally-design modes of intervention that are founded on strong biological mechanisms and be comprehensive, multi-dimensional, and appropriately tailored to the degree of malignant potential of an early lesion.

This Notice is being provided to allow potential applicants sufficient time to develop a responsive, multicomponent TBEL application. The companion notice for the TBEL Coordinating and Data Management Center (CDMC; U24) is: NOT-CA-21-061.

The FOA is expected to be published in Summer 2021 with an anticipated application due date in Fall 2021. Details of the planned pre-application webinar will be announced in the Guide after publication of the FOA.

The FOA will utilize the U54 (Specialized Center--Cooperative Agreements) activity code.

Research Initiative Details

Increasingly sensitive imaging/cancer-screening modalities have led to the detection of a significant number of precancers and early cancers, whose clinical management present a serious challenge, as it is often not possible – without understanding the underlying biology – to determine those that will progress (and require intervention) or remain indolent (for which active surveillance may suffice). Despite the strong links between early lesions and cancer risk for many tumor types and numerous clinical conditions ranging from chronic inflammation to obesity/metabolic disorders, and tissue stiffness/desmoplasia, only limited insights exist in the nexus between early lesion drivers and regulators of malignant progression. Elucidation of basic mechanisms driving or restraining precancers/early cancers would allow differentiation and stratification between aggressive, potentially lethal cancers (“clinically important cancers”) and indolent types and further personalize care.

The TBEL Centers will be structured to efficiently bridge gaps between basic and translational research on early lesions and their microenvironments. Each TBEL Center will have a multi-PI structure with appropriately diversified and complementary expertise spanning the basic-translational spectrum to achieve the goals of the Center and the entire program. Each Center will be organized around a minimum of three synergistic and complementary research projects unified towards testing a central hypothesis and one to two Resource Cores as follows:

• Two basic/mechanistic projects and one translational project, or

• Two translational projects and one basic/mechanistic project, and

• Relevant cores to support project integration and iteration.

Relevant basic/mechanistic research areas include (but are not limited to):

  • Tumor & stromal landscape of lesion drivers and suppressors based on position-dependent functional organization/heterogeneity/reciprocal interactions.
  • Mechanisms of cell-cell and cell-extracellular matrix (ECM)-based changes and tissue/microenvironmental reprogramming events that may influence transformation, malignant progression and/or indolence.
  • Development of novel or repurposed early lesion platforms (and companion human resources) to interrogate complex ECM-stromal cell-nascent tumor cell interactions in malignant progression.

Relevant translational research areas include (but are not limited to):

  • Molecular “-omic” evaluation of recurrent and non-recurrent screen-detected lesions, interval lesions and incidentalomas to identify unique and/or shared aggressive or indolent features.
  • Integrating phenotypes of the cellular and stromal components in early lesions with molecular signatures that may predict increased cancer-specific mortality.
  • Adopting sequential imaging approaches to elucidate dynamic changes in progressive disease to provide insights into molecular and cellular events linked to lethal cancer versus non-lethal disease.

The TBEL FOA will not be restricted to specific early lesion/cancer type(s), however, the rationale must be clearly articulated in the context of the Center’s theme and proposed hypothesis to be tested.

More details will be outlined in the forthcoming RFA.

Funding Information
Estimated Total Funding

NCI intends to commit up to $8.182 million for Fiscal Year 2022

Expected Number of Awards


Estimated Award Ceiling

Each U54 application budget will be limited to $1.0 million (direct cost) per year for a total of five years.

Primary Assistance Listing Number(s)

93.395, 93.396

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 


Please direct all inquiries to:

For Biology Research
Elisa Woodhouse, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)

Rihab Yassin, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
Telephone: 240-276-6230

For Translation and Prevention Research
Christos Patriotis, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-7134

Sharmistha Ghosh-Janjigian, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-7122

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices