Opportunity Information: Apply for PAR 15 289
Apply for PAR 15 289
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "The Pancreatic Cancer Detection Consortium (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research.
- This funding opportunity was created on Jun 30, 2015 and posted on Jun 30, 2015.
- Applicants must submit their applications by Apr 6, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Private institutions of higher education Public housing authorities/Indian housing authorities City or township governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses County governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Pancreatic Cancer Detection Consortium (PCDC) (U01) funding opportunity (PAR 15-289) was a National Institutes of Health cooperative agreement announcement designed to build a coordinated, multi-site research effort focused on finding better ways to detect pancreatic ductal adenocarcinoma (PDAC) at an early, more treatable stage and to improve how clinicians identify and characterize PDAC precursor lesions. The program was positioned as a direct response to a major research priority laid out in the National Cancer Institute's 2014 Scientific Framework for PDAC, reflecting the reality that pancreatic cancer is often diagnosed late and that earlier detection and clearer risk stratification could meaningfully change outcomes.
Under this FOA, NIH sought applications from multidisciplinary teams that combine clinical expertise (such as gastroenterology, surgery, pathology, radiology, and oncology) with research capabilities (including molecular biology, genomics, proteomics, biomarker science, imaging science, biostatistics, and computational methods). These funded teams were organized as individual "Units" within the larger consortium. Each Unit was expected to conduct its own research program while also functioning as part of a coordinated network, meaning the work was not intended to be isolated lab projects but rather interoperable studies that could be compared, combined, and validated across sites.
The scientific scope emphasized development and testing of molecular and imaging biomarkers aimed at identifying people at elevated risk for PDAC, including individuals with inherited or genetic risk factors and people with pancreatic precursor lesions. A major part of the research focus involved biomarkers measurable in bodily fluids, which typically refers to minimally invasive or noninvasive sample types like blood, plasma or serum, urine, saliva, stool, or pancreatic fluid depending on clinical context. The goal in this area was to move toward practical early-detection tools that could be used in real-world screening or surveillance settings rather than relying solely on late-stage symptoms or incidental imaging findings.
Another central objective was improving prediction of which pancreatic cysts are likely to progress to cancer. Because pancreatic cystic lesions are common and heterogeneous, a key clinical problem is distinguishing cysts that are relatively indolent from those that represent higher malignant potential. The FOA therefore encouraged studies that integrate molecular signatures, imaging characteristics, and clinical variables to improve cyst risk stratification, reduce unnecessary procedures for low-risk lesions, and ensure high-risk lesions receive timely intervention.
The program also supported the development of molecular and/or imaging-based screening approaches tailored to high-risk populations. This includes research on how best to deploy advanced imaging, radiologic feature extraction, endoscopic approaches, or combined biomarker-plus-imaging strategies for surveillance in cohorts such as those with strong family histories, known pathogenic variants, or established precursor lesions. Importantly, the intended direction was not broad population screening, but targeted methods that are clinically feasible and appropriately calibrated for groups where the benefit-risk balance is more favorable.
A required element across Units was biomarker validation, which typically means moving beyond discovery to testing performance in well-designed studies that address sensitivity, specificity, reproducibility, and clinical utility. Closely tied to this was the expectation to collect longitudinal biospecimens and associated data, enabling researchers to study changes over time and to link biomarker signals with future clinical outcomes. These collections were meant to feed into the establishment of a biorepository, strengthening the consortium's ability to validate findings across cohorts and to accelerate follow-on studies by providing standardized, well-annotated specimen resources.
Because the award mechanism was a U01 cooperative agreement, NIH anticipated substantial scientific and programmatic involvement beyond what is typical for standard research grants. In practice, this structure is commonly used when an agency wants active coordination across awardees, harmonized protocols, shared resources, and regular consortium-wide decision-making. Consistent with that model, Units were expected to participate in collaborative activities with other Units and to share ideas, specimens, and data within the consortium, reinforcing that progress in early detection would require pooled expertise, common standards, and cross-site validation rather than fragmented efforts.
Administratively, the opportunity was categorized as discretionary funding and aligned with the health and education activity areas, with CFDA number 93.394 (Cancer Detection and Diagnosis Research). It did not require cost sharing or matching. The FOA was posted June 30, 2015, with an original and final closing date of April 6, 2018, and it was archived May 7, 2018, indicating the solicitation is no longer open but remains available for reference. Eligible applicants were broad and included public and private institutions of higher education, nonprofit organizations with and without 501(c)(3) status, small businesses and other for-profit entities (with the noted distinction for small businesses), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities. The eligibility language also explicitly included a range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and other minority-serving institutions, as well as faith-based or community-based organizations and eligible federal agencies, reflecting an inclusive stance toward who could participate in this research effort.
Overall, the PCDC U01 opportunity was structured to accelerate early detection of pancreatic cancer by creating a collaborative ecosystem that could discover, test, and validate biomarkers and imaging approaches, build longitudinal specimen resources, and improve clinical decision-making for high-risk individuals and patients with pancreatic precursor lesions, with the long-term aim of enabling earlier intervention and improving patient outcomes.
Frequently Asked Questions (FAQs) - Pancreatic Cancer Detection Consortium (PCDC) (U01), PAR 15-289
What is the PCDC (U01) funding opportunity (PAR 15-289)?
The Pancreatic Cancer Detection Consortium (PCDC) (U01) opportunity (PAR 15-289) was a National Institutes of Health (NIH) cooperative agreement announcement designed to build a coordinated, multi-site research program focused on improving early detection of pancreatic ductal adenocarcinoma (PDAC) and improving identification and characterization of PDAC precursor lesions.
What is the main purpose of this consortium?
The main purpose was to accelerate progress toward earlier, more treatable detection of PDAC and better clinical decision-making for precursor lesions by organizing multiple research teams into a coordinated network that could develop, test, and validate biomarkers and imaging approaches across sites.
Why was the program created?
The program was positioned as a direct response to priorities in the National Cancer Institute's 2014 Scientific Framework for PDAC, reflecting that pancreatic cancer is often diagnosed late and that earlier detection and clearer risk stratification could meaningfully improve outcomes.
What does PDAC stand for?
PDAC stands for pancreatic ductal adenocarcinoma, a major form of pancreatic cancer and a central focus of this funding opportunity.
What is meant by "early detection" in the context of this program?
Early detection refers to finding PDAC at an earlier stage when it is more treatable, and developing practical tools and approaches that can be used in real-world screening or surveillance settings (especially for people at elevated risk).
What is a U01 cooperative agreement, and why does it matter?
A U01 is a cooperative agreement mechanism where NIH anticipates substantial scientific and programmatic involvement beyond what is typical for standard research grants. For this program, it meant active coordination across awardees, harmonized protocols, shared resources, and consortium-wide decision-making, with Units expected to collaborate and share data and specimens within the consortium.
How was the consortium organized?
Funded teams were organized as individual "Units" within the consortium. Each Unit was expected to conduct its own research program while also operating as part of a coordinated network, enabling interoperable studies that could be compared, combined, and validated across multiple sites.
What kinds of research teams did NIH want to fund?
NIH sought multidisciplinary teams that combine clinical expertise (for example, gastroenterology, surgery, pathology, radiology, and oncology) with research capabilities (such as molecular biology, genomics, proteomics, biomarker science, imaging science, biostatistics, and computational methods).
What were the main scientific research areas supported by this FOA?
The scope emphasized development and testing of molecular and imaging biomarkers for early detection and risk identification, improvement of prediction for which pancreatic cysts may progress to cancer, and development of molecular and/or imaging-based screening approaches tailored to high-risk populations, with a strong emphasis on biomarker validation and longitudinal biospecimen collection.
What kinds of biomarkers were emphasized?
The FOA emphasized molecular and imaging biomarkers, including biomarkers measurable in bodily fluids, with the goal of advancing minimally invasive or noninvasive early-detection tools suitable for screening or surveillance in appropriate clinical contexts.
What does "biomarkers measurable in bodily fluids" mean here?
It refers to biomarkers that can be measured from sample types that are typically minimally invasive or noninvasive, such as blood (including plasma or serum), urine, saliva, stool, or pancreatic fluid, depending on clinical context.
Who was the early detection work intended to help?
The program particularly emphasized identifying people at elevated risk for PDAC, including individuals with inherited or genetic risk factors and people who have pancreatic precursor lesions.
Did the FOA support general population screening for pancreatic cancer?
No. The intended direction was not broad population screening, but targeted screening and surveillance methods calibrated for high-risk groups where the benefit-risk balance is more favorable.
What high-risk populations were mentioned in the opportunity description?
Examples included cohorts with strong family histories of pancreatic cancer, people with known pathogenic variants (genetic risk factors), and individuals with established precursor lesions.
Why was there a focus on pancreatic cysts?
Because pancreatic cystic lesions are common and heterogeneous, a major clinical problem is distinguishing relatively indolent cysts from those with higher malignant potential. The FOA encouraged research to improve prediction of which cysts are likely to progress to cancer.
What types of approaches were encouraged for pancreatic cyst risk stratification?
The FOA encouraged studies integrating molecular signatures, imaging characteristics, and clinical variables to improve cyst risk stratification, reduce unnecessary procedures for low-risk lesions, and ensure high-risk lesions receive timely intervention.
What kinds of screening or surveillance approaches did the FOA support?
It supported development of molecular and/or imaging-based screening approaches for high-risk populations, including research involving advanced imaging, radiologic feature extraction, endoscopic approaches, and combined biomarker-plus-imaging strategies for surveillance.
Was biomarker validation required?
Yes. A required element across Units was biomarker validation, meaning moving beyond discovery to testing performance in well-designed studies addressing sensitivity, specificity, reproducibility, and clinical utility.
What did the FOA say about longitudinal biospecimens and data collection?
The program expected collection of longitudinal biospecimens and associated data so researchers could evaluate changes over time and link biomarker signals with future clinical outcomes.
Was there an emphasis on building a biorepository?
Yes. Longitudinal specimen collections were intended to support establishment of a biorepository and strengthen the consortium's capacity to validate findings across cohorts using standardized, well-annotated specimen resources.
What were the collaboration expectations for funded Units?
Because this was a consortium-based cooperative agreement, Units were expected to participate in collaborative activities, share ideas, and share specimens and data within the consortium to enable pooled expertise, common standards, and cross-site validation.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What was the CFDA number associated with this opportunity?
The CFDA number listed was 93.394, Cancer Detection and Diagnosis Research.
How was the funding categorized administratively?
It was categorized as discretionary funding and aligned with the health and education activity areas.
When was the FOA posted, and when did it close?
The FOA was posted on June 30, 2015. The original and final closing date was April 6, 2018.
Is this funding opportunity still open?
No. It was archived on May 7, 2018, indicating the solicitation is no longer open and remains available for reference.
Who was eligible to apply under this FOA?
Eligibility was broad and included public and private institutions of higher education, nonprofit organizations with and without 501(c)(3) status, small businesses and other for-profit entities (with a distinction noted for small businesses), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities.
Did the eligibility language include minority-serving institutions?
Yes. The eligibility language explicitly included institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and other minority-serving institutions.
Were faith-based or community-based organizations eligible?
Yes. The eligibility language explicitly included faith-based or community-based organizations.
Could foreign (non-U.S.) organizations apply?
Yes. Foreign (non-U.S.) entities were included among eligible applicants.
What was the long-term aim of the PCDC U01 program?
The long-term aim was to enable earlier intervention and improve patient outcomes by accelerating development, testing, and validation of early detection biomarkers and imaging approaches, strengthening longitudinal specimen resources, and improving clinical decision-making for high-risk individuals and patients with precursor lesions.
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