Consortium on Translational Research in Early Detection of Liver Cancer: Translational Research Centers (U01 Clinical Trial Optional) | RFA CA 22 031

Frequently Asked Questions (FAQs)

What is the main goal of this NIH funding opportunity?

The Funding Opportunity Announcement (FOA) is intended to build a coordinated Liver Cancer Consortium focused on moving promising early detection ideas closer to real-world use. The emphasis is on translational research that connects laboratory discoveries and technology development with clinical studies to improve how liver cancer is found and managed in people at high risk.

What specific problems in liver cancer care is the Consortium trying to address?

The FOA highlights three major aims: strengthening liver cancer surveillance, increasing the proportion of cancers detected at an earlier and more treatable stage, and improving how clinicians identify and stratify patients who are most likely to develop liver cancer.

What kind of research does NIH mean by "translational" in this FOA?

In this program, translational research means work that bridges laboratory and technology development with clinical studies, with the expectation that outputs can directly improve early detection and clinical management in high-risk populations.

What award mechanism is being used to fund the Translational Research Centers (TRCs)?

NIH will fund several Translational Research Centers (TRCs) through U01 cooperative agreements. The FOA notes that clinical trials are optional.

Why is this considered a cooperative agreement rather than a typical grant?

The U01 mechanism is a cooperative agreement, which generally involves substantial, ongoing interaction among NIH and the awardees. For this Consortium, that includes coordination around milestones, shared protocols, governance, and cross-site collaboration.

How many awards does NIH expect to make, and what is the budget ceiling?

NIH anticipated making about five awards. The listed award ceiling is $550,000.

What is the FOA number and CFDA listing?

The FOA is identified as RFA-CA-22-031. The activity category is health and education, and the CFDA listing provided is 93.394.

When was the opportunity created and what closing date is shown?

The opportunity record indicates a creation date of August 15, 2022. The original closing date shown in the provided information is November 7, 2022.

What are Translational Research Centers (TRCs) expected to do under this FOA?

TRCs are expected to run well-designed studies that address key gaps in current liver cancer surveillance. This includes work related to how surveillance findings that are not clearly benign or malignant (for example, indeterminate findings) should be handled and interpreted during routine monitoring.

What is the central Consortium-wide deliverable mentioned in the FOA?

A major scientific and operational deliverable is the creation of an integrated blood and imaging repository linked to carefully annotated clinical data. The FOA places particular emphasis on patients who present with indeterminate liver nodules during surveillance.

What types of data and samples are expected to be included in the repository?

Participating centers are expected to collect and harmonize biospecimens (such as blood-based samples), imaging data, and standardized clinical metadata. These materials are intended to support validation of biomarkers, imaging-based signatures, and multimodal approaches for earlier and more accurate detection.

Why does the FOA emphasize patients with indeterminate liver nodules?

The FOA specifically calls out indeterminate liver nodules encountered during surveillance as a key area of emphasis for the integrated repository and associated clinical annotation, reflecting a recognized gap in how uncertain findings are managed and interpreted.

What does "harmonize" mean in the context of this Consortium?

Based on the FOA description, harmonization means aligning how sites collect biospecimens, imaging, and clinical metadata so the resulting repository and datasets can be used for cross-center validation and comparison rather than remaining siloed within a single institution.

What kinds of approaches is the Consortium expected to validate?

The FOA describes validation efforts for blood-based biomarkers, imaging-based signatures, and combined multimodal methods that integrate more than one data type to improve early and accurate detection.

What disciplines and expertise are expected within a competitive TRC application?

TRCs are expected to be genuinely multidisciplinary. The FOA describes teams that bring together laboratory scientists and clinical investigators with complementary expertise spanning early cancer detection, biomarker discovery and validation, surveillance strategy design, radiology and imaging analytics, and biospecimen science (including standardized collection, processing, storage, and quality control).

How important is collaboration across sites?

Collaboration is a central theme. The FOA emphasizes consortium-scale progress rather than isolated projects, and expects awardees to align protocols, contribute data and samples to shared efforts, and participate in joint planning, analysis, and problem-solving across sites.

What are the two main components of the Consortium?

The Consortium has two main components: (1) Translational Research Centers (TRCs) funded under this FOA through U01 awards, and (2) a Data Management and Coordinating Center (DMCC) supported through a separate companion FOA using a U24 mechanism.

What is the Data Management and Coordinating Center (DMCC), and how is it funded?

The DMCC is intended to provide the data infrastructure and coordinating functions needed to run a multi-site consortium efficiently. It is supported by a separate, companion FOA using a U24 mechanism (RFA-CA-21-032).

What functions is the DMCC expected to provide?

As described, the DMCC supports common data elements, harmonized workflows, repository integration, and cross-center collaboration support to help the consortium operate efficiently across multiple sites.

Are TRCs expected to work with the DMCC?

Yes. TRCs funded through the U01 are expected to work closely with the DMCC and with one another, consistent with the cooperative agreement structure and the goal of coordinated multi-site progress.

What types of organizations are eligible to apply?

The FOA allows a wide range of U.S.-based organizations to apply, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; and nonprofit and for-profit organizations (including small businesses).

Does the FOA encourage participation from specific institution types or communities?

Yes. The announcement explicitly encourages participation from mission-driven and community-rooted institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Can non-U.S. (foreign) institutions apply as the applicant organization?

No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply as applicants under the FOA, based on the provided information.

Are foreign components allowed at all?

Foreign components are allowed as defined by the NIH Grants Policy Statement, which can enable certain international collaborations when appropriately justified and compliant with NIH rules.

What is the overall intent of building a coordinated consortium rather than funding isolated projects?

The FOA is designed to accelerate progress in early liver cancer detection by combining multi-site clinical cohorts, standardized surveillance-related data and samples, and coordinated translational research that can be validated and compared across centers rather than remaining siloed at a single institution.