Pancreatic Cancer Detection Consortium: Research Units (U01 Clinical Trial Optional)

Through this Notice of Funding Opportunity (NOFO), NCI solicits applications for the Research Units (RUs), one of the two scientific components of the Pancreatic Cancer Detection Consortium (PCDC), to conduct research on early detection of pancreatic ductal adenocarcinoma (PDAC) and characterization of its precursor lesions to identify patients who are at high risk of progression to cancer. The PCDC will continue to address one of the four research priorities identified in the NCI's 2014 Scientific Framework for Pancreatic Ductal Adenocarcinoma (PDAC). The PCDC will support research for the development and testing of new molecular and imaging biomarkers for detecting PDAC early and for identifying patients at high risk of PDAC (because of genetic factors, family history and/or the presence of precursor lesions) who could be candidates for early intervention. The PCDC-RUs will consist of multi-disciplinary teams and will undertake studies to: identify and test biomarkers measurable in bodily fluids for early detection of PDAC and/or its precursor lesions; develop molecular- and/or imaging-based markers of pancreatic cysts and determine which lesions are likely to progress to cancer; develop molecular- and/or imaging-based approaches for screening populations at high risk of PDAC; use machine learning and computational approaches towards biomarker discovery and/or validation; and conduct biomarker validation studies. The PCDC-RUs will also collect longitudinal biospecimens for building a biorepository. Each PCDC-RU is expected to participate in collaborative activities with other PCDC-RUs and share ideas, biospecimens, and data within the Consortium.

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; 2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...