NOT-CA-21-099: Notice of Intent to Publish a Funding Opportunity Announcement for Pancreatic Cancer Detection Consortium: Management and Data Coordination Unit (U24 Clinical Trial Not Allowed)

Notice of Intent to Publish a Funding Opportunity Announcement for Pancreatic Cancer Detection Consortium: Management and Data Coordination Unit (U24 Clinical Trial Not Allowed)

Notice Number:

NOT-CA-21-099

Key Dates

Release Date:

July 22, 2021

Estimated Publication Date of Funding Opportunity Announcement:

August 20, 2021

First Estimated Application Due Date:

November 15, 2021

Earliest Estimated Award Date:

July 01, 2022

Earliest Estimated Start Date:

July 01, 2022

Related Announcements

NOT-CA-21-098 - Notice of Intent to Publish a Funding Opportunity Announcement for Pancreatic Cancer Detection Consortium: Research Units (U01 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) plans to publish a Funding Opportunity Announcement (FOA) for the establishment of the Management and Data Coordination Unit (MDCU), one of the two scientific components of the Pancreatic Cancer Detection Consortium (PCDC). The PCDC will conduct research on early detection of pancreatic ductal adenocarcinoma (PDAC) and characterization of its precursor lesions to identify those patients who are at high risk of progression to cancer. The PCDC is a continuing program addressing one of the four research priorities identified in the National Cancer Institute's 2014 Scientific Framework for Pancreatic Ductal Adenocarcinoma. The MDCU will provide support toward study design, protocol development, statistical analysis, coordination and data management of trans-PCDC collaborative projects, biorepository building, and organizational and logistics support for Consortium-wide calls, meetings and workshops.

The other scientific component of the PCDC will be the Research Units (PCDC-RUs). The PCDC-RUs will conduct research for the development and testing of new molecular and imaging biomarkers for early detection of PDAC and/or for identifying those patients at high risk of PDAC (because of genetic factors and/or family history or presence of precursor lesions) who could be candidates for early intervention.

This Notice of Intent to Publish (NOITP) is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive applications. Companion notice for the PCDC-RU is: NOT-CA-21-098.

The PCDC-MDCU FOA is expected to be published in Summer 2021 with an expected first application due date in Fall2021.

The PCDC-MDCU FOA will utilize the U24 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The PCDC-MDCU will serve as the organizational hub for the entire PCDC program and must have a comprehensive plan for overall program coordination, administration, facilitating steering committee and working group meetings, data management, and biostatistical support for collaborative studies. The PCDC-MDCU will provide overall consortium coordination support, integrate collaborative efforts across the program, facilitate/coordinate trans-PCDC projects, and coordinate an important biorepository building effort (described below). The MDCU must have expertise and capabilities in the areas mentioned above.

A major impediment to pancreatic cancer research is limited access to well-characterized and well-annotated specimens from early stages and lethal precursors that can be used to discover and validate biomarkers. The development of extensive and efficient registries to explore novel approaches to early detection of pancreatic cancer is a necessary resource in the field. The PCDC is addressing these challenges by building two longitudinal biorepositories. This ongoing activity is highly important to the NCI and will continue in the new funding period. It is a multi-institutional, unique collection of prospective, longitudinal biospecimens (blood [serum, plasma], cyst fluid, pancreatic juice) from two types of high-risk cohorts: (1) individuals at high risk of PDAC because of genetic factors or family history, and (2) individuals at high risk of PDAC because of the presence of pancreatic cysts (e.g. mucinous cysts). These cohorts are called "PCDC Signature Cohorts”. The collection of sufficient biospecimens will enable the design of adequately powered biomarker validation studies. One of the main functions of the PCDC-MDCU will be to support this activity, which will include, but is not limited to: tracking/documenting enrollment and working with the PCDC-RUs to meet enrollment and centralized data deposition goals, building and maintaining a virtual database, support with deidentification of biospecimen and/or imaging data, lead blinding and unblinding procedures for trans-PCDC validation projects, and coordinate/facilitate the transfer of biospecimens to the NCI at Frederick Central Repository.

It is essential that the PCDC-MDCU applicants familiarize themselves with the companion FOA for the PCDC-RUs.

The FOA will be open to all qualified applicants, including new and early-stage investigators, who can establish and lead a multi-disciplinary, multi-Principal Investigator research project to enable the fulfillment of the intended program goals.

More details will be outlined in the forthcoming FOA.

Funding Information

Estimated Total Funding

NCI intends to commit $825,000 total cost for the first year.

Expected Number of Awards

One

Estimated Award Ceiling

$500,000 direct cost per year.

Primary Assistance Listing Number(s)

93.394

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
State Government
Eligible Agencies of the Federal Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Sudhir Srivastava, Ph.D., M.P.H.

National Cancer Institute (NCI)

240-276-7028

Email: srivasts@mail.nih.gov

Sharmistha Ghosh-Janjigian, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7122
Email: ghoshjanjigias@mail.nih.gov

Matthew Young, Ph.D.
National Cancer Institute (NCI)
Telephone:240-276-5846
Email: youngma@mail.nih.gov