Friday, August 22, 2025 8/22/2025

Validation of biomarkers for risk prediction and early diagnosis of Pancreatic Adenocarcinoma

Award Number: U01CA200466
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/17/2016
PERIOD OF PERFORMANCE END DATE: 03/31/2028

Group Awards By:

View Award Description

Validation of biomarkers for risk prediction and early diagnosis of Pancreatic Adenocarcinoma - Abstract Pancreatic adenocarcinoma (PDAC), with an overall 5-year survival of 11%, is the 3rd most common cause of cancer deaths in the United States, despite accounting for only 2% of all malignancies. Only a minority of patients (~11%) are diagnosed with “localized” disease (I or IIA), which has a 5-year survival rate of about 40% in setting of a node-negative, margin negative pancreatic resection. An obvious strategy for improving the dismal survival would be to detect PDAC when localized and thus at a more curable stage. Since screening the general population for PDAC is not feasible, current efforts have focused on identifying a subset of the people at an increased risk for PDAC development. Currently, only up to 25% of individuals who develop PDAC are candidates for pancreatic cancer surveillance. About 10% are individuals with a strong family history or a combination of family history and germline mutations associated with the risk of PDAC development. The other ~15% are individuals with cystic neoplasms of the pancreas, including IPMNs and MCNs. The inability to predict the malignant transformation of mucinous cysts and thus identify the cysts that should be surgically removed requires appropriate surveillance. Despite developing multiple consensus guidelines on managing cystic lesions, it is still challenging to determine which mucinous cysts will undergo malignant transformation. During the previous funding cycle, we identified and evaluated novel serum biomarker panels comprising mucins (MUC4, MUC5AC), mucin-associated glycoepitopes (STRA), TGM2, THSP2, TIMP2, and autoantibodies that were validated in a blinded case-control cohort aimed at detecting resectable PDAC. Preliminary mutational profiling of pancreatic cyst fluid (phase I and II) identified a unique panel (PancreaSeq) that helped define the malignant risk of pancreatic cysts. The goal of the current Clinical Validation Center (CVC) is to validate further these panel(s) in a prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) compliant manner in cohorts of high-risk individuals who are current or potential candidates for early detection or diagnosis of PDAC. Aim 1 will validate cyst fluid and blood-based biomarkers in patients with cystic lesions to identify advanced precursor lesions and differentiate low-grade dysplasia and no lethal potential. In this aim, we will validate candidate biomarkers, including PancreaSeq mutational panel (Phase 3), inflammatory markers (Phase 2), and mucins (MUC4, MUC5AC, STRA) (Phase 3) in the cyst fluid (high specificity) and serum samples (high sensitivity) to identify interval malignancy during surveillance imaging. Aim 2 will evaluate the performance of optimized biomarker panel(s) for early detection of malignant disease in patients with a hereditary predisposition undergoing surveillance for PDAC development and in patients with new-onset diabetes and chronic pancreatitis, defined as within two years of initial diagnosis, who are at a significantly increased risk compared to the general population for having an undiagnosed PDAC. Impact: The proposed studies will validate the clinical utility of promising biomarker panels for early detection of PDAC and risk stratification of pancreatic cystic lesions, which can be used in phase IV clinical utility studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,264,325 )
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	8	3/21/2025	NON-COMPETING CONTINUATION	$1,137,892
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	8	5/22/2025	NON-COMPETING CONTINUATION	$126,433
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	7	3/26/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	7	1/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,264,325

Issue Date FY: 2024 ( Subtotal = $1,201,109 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	7	3/14/2024	NON-COMPETING CONTINUATION	$1,137,893
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	7	4/17/2024	NON-COMPETING CONTINUATION	$63,216
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	7	4/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,201,109

Issue Date FY: 2023 ( Subtotal = $910,957 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	6	4/24/2023	COMPETING CONTINUATION	$915,566
2023	2021	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	4/12/2023	SUPPLEMENT FOR EXPANSION	-$4,609
														Subtotal = $910,957

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	5	3/10/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	3/10/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $617,452 )
2021	2021	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	5	4/30/2021	SUPPLEMENT FOR EXPANSION	$617,452
2021	2020	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	10/29/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $617,452

Issue Date FY: 2020 ( Subtotal = $875,414 )
2020	2020	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	5	6/4/2020	NON-COMPETING CONTINUATION	$875,414
2020	2019	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	4	2/3/2020	NON-COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	4	11/21/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $875,414

Issue Date FY: 2019 ( Subtotal = $857,224 )
2019	2019	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	4	4/1/2019	NON-COMPETING CONTINUATION	$857,224
2019	2018	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	3	10/24/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $857,224

Issue Date FY: 2018 ( Subtotal = $1,563,388 )
2018	2018	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	3	8/28/2018	NON-COMPETING CONTINUATION	$113,170
2018	2018	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	3	3/29/2018	NON-COMPETING CONTINUATION	$1,450,218
														Subtotal = $1,563,388

Issue Date FY: 2017 ( Subtotal = $1,667,463 )
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	2	6/8/2017	NON-COMPETING CONTINUATION	$88,409
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	2	8/29/2017	NON-COMPETING CONTINUATION	$653,686
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	2	4/3/2017	SUPPLEMENT FOR EXPANSION	$129,694
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	2	3/22/2017	NON-COMPETING CONTINUATION	$795,674
														Subtotal = $1,667,463

Issue Date FY: 2016 ( Subtotal = $1,074,631 )
2016	2016	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	1	9/20/2016	NEW	-$171,812
2016	2016	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	1	5/17/2016	NEW	$902,819
2016	2016	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	1	8/8/2016	NEW	$171,812
2016	2016	UNIVERSITY OF PITTSBURGH	123 UNIVERSITY PLACE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	1	9/20/2016	SUPPLEMENT FOR EXPANSION	$171,812
														Subtotal = $1,074,631

Grand Total All Awards = $10,031,963

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Validation of biomarkers for risk prediction and early diagnosis of Pancreatic Adenocarcinoma

Award Number: U01CA200466

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/17/2016

PERIOD OF PERFORMANCE END DATE: 03/31/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer