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)
National Cancer Institute (NCI)
The National Cancer Institute (NCI) plans to publish a Funding Opportunity Announcement (FOA) for the establishment of the Research Units (RUs), 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 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..
The other scientific component of the PCDC will be the Management and Data Coordination Unit (MDCU). The PCDC-MDCU will serve as the organizational hub for the entire PCDC program. The PCDC-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.
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-MDCU is: NOT-CA-21-099.
The FOA for PCDC-RUs is expected to be published in Summer 2021 with an expected first application due date in Fall2021.
The PCDC-RUs FOA will utilize the U01 activity code. Details of the planned FOA is provided below.
The PCDC-RUs will consist of multi-disciplinary teams and will undertake studies to: develop and test biomarkers measurable in bodily fluids and imaging methods for improved detection of early-stage PDAC, and high-grade lethal precursors (e.g., mucinous cysts); develop and test biomarkers and imaging methods to determine which precursor lesions are likely to progress to cancer; study cancerization of pancreatic ducts to identify biomarkers that can help detect cancer early; develop molecular- and/or imaging-based approaches for screening populations at high risk of PDAC to detect cancer early; use machine learning and computational approaches for biomarker discovery and/or validation; conduct biomarker validation studies; and collect prospective, longitudinal biospecimens for contribution to a biorepository.
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. The PCDC-RUs are expected to participate in the recruitment of high-risk patients and collect biospecimens (blood and other biofluids), both for the PCDC Signature Cohorts and for building case-control reference sets. The NCI also expects that a portion of the biospecimens will be transferred to the NCI at Frederick Central Repository to build the physical repositories.
Each PCDC-RU is also expected to participate in collaborative activities with other PCDC-RUs and share ideas, biospecimens and data within the Consortium. The multidisciplinary teams should include biologist(s), epidemiologist(s), pathologist(s), radiologist(s), statistician(s), clinician(s), a research coordinator, and investigators with imaging expertise (if applicable). Each PCDC-RU will be supported by an individual U01 cooperative agreement award.
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.
NCI intends to commit an estimated $2.8 million total cost in the first year.
$600,000 direct cost per year.
Applications are not being solicited at this time.
Please direct all inquiries to:
Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)