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

> **NIH NIH U01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $1,201,109

## Abstract

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 diagn...

## Key facts

- **NIH application ID:** 10832118
- **Project number:** 5U01CA200466-07
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Surinder K. Batra
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,201,109
- **Award type:** 5
- **Project period:** 2016-05-17 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10832118

## Citation

> US National Institutes of Health, RePORTER application 10832118, Validation of biomarkers for risk prediction and early diagnosis of Pancreatic Adenocarcinoma (5U01CA200466-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10832118. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*