# Urine and serum biomarkers for early diagnosis and risk assessment of pancreatic cancer

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $637,390

## Abstract

ABSTRACT
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers, primarily due to most cases being
diagnosed at an advanced, incurable stage. While 5-year survival of metastatic PDAC is <5%, outcomes
dramatically improve for localized PDAC. Poor prognosis is due to a lack of biomarkers for diagnosing PDAC at
an early, asymptomatic stage when cure is possible. Effective diagnosis of early stage PDAC depends on
identification of accurate, non-invasive biomarkers in combination with a strategy for screening increased risk
populations. Our primary objective is to identify non-invasive protein biomarkers in serum, urine, and exosomes
that accurately distinguish between patients with and without early stage resectable PDAC that is amenable to
curative surgery. Novel diagnostics would also improve discrimination between PDAC and benign pancreatic
pathologies. The goal of the proposed research is to develop clinically translatable noninvasive biomarkers-
based tests for screening (in high risk groups) and differential diagnosis of PDAC. Our central hypothesis is that
combinations of urinary, serum, and exosome derived biomarkers could be synergistic offering a superior
classification power. We have used urine and serum samples from retrospective and prospective cohort studies
to identify a range of strong candidate combinatorial multimarker algorithms for early detection and diagnosis of
PDAC. In Aim 1, we will optimize the performance of a PDAC differential diagnosis algorithm and will validate
the optimized algorithm in samples collected prior to clinical diagnosis in the Pancreatic Adenocarcinoma Gene
Environment Risk (PAGER) study. In Aim 2, we will optimize the performance of an early detection algorithm for
resectable PDAC in pre-diagnostic samples from three prospectively collected cohorts and validate the optimized
EDA in blinded parallel serum/urine samples from the Southern Community Cohort Study (SCCS). If successful,
our project will yield novel, validated algorithms for risk assessment and early detection and for differential
diagnosis of PDAC. These algorithms when combined will result in a new pioneering screening paradigm for
PDAC allowing for timely live-saving interventions. Our strong preliminary data, powerful and synergistic
investigative team, and the availability of parallel urine and serum samples from unique prospective cohorts
contribute to the high probability of successful accomplishing the proposed studies.

## Key facts

- **NIH application ID:** 10156494
- **Project number:** 1R01CA254036-01A1
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Surinder K. Batra
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $637,390
- **Award type:** 1
- **Project period:** 2021-02-03 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10156494

## Citation

> US National Institutes of Health, RePORTER application 10156494, Urine and serum biomarkers for early diagnosis and risk assessment of pancreatic cancer (1R01CA254036-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10156494. Licensed CC0.

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