# Circulating Biomarkers and Imaging for Early Detection of Pancreatic Cancer

> **NIH NIH U01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2022 · $1,013,807

## Abstract

PROJECT SUMMARY
Biomarkers for the early detection of pancreatic cancer are urgently needed. However, individual molecules
with the sensitivity and specificity needed for population-based screening have not been discovered. CA-19-9
has been studied extensively and yet has failed to demonstrate the predictive value necessary for early
detection and diagnosis. Although many platforms, including proteomic, genomic and transcriptomic
approaches have been utilized and biomarker candidates identified, no one platform or molecule has been
successfully validated in large blinded population screens. We have taken a functional genomic pathways
approach to biomarker discovery targeting the earliest genomic intervals altered in pancreatic and other
smoking related cancers, focusing on biomarkers involved in critical cancer relevant cellular pathways. We
have identified a “migration signature” and biomarker panel that has gone through two blinded validations
including the NCI-EDRN pancreatic cancer reference set of early stage disease and benign and healthy
controls. Results indicate that our panel of biomarkers improves the performance of CA19-9 to detect
asymptomatic early stage pancreatic cancer yielding significant results across validations platforms. We have
developed plasma miRNA biomarker panels for pancreatic cancer and validated these in multiple trials. The
combination of our biomarkers demonstrates high sensitivity and specificity to detect early stage pancreatic
cancer. We will further refine this early stage biomarker panel and a novel risk score approach to stratify the
general population and at risk population for screening. Refined panels will be validated in large retrospective
and prospective cohorts for early detection of pancreatic cancer according to ProBE design. In order that we
identify early stage disease prior to metastasis, amenable to curative intervention, we will utilize a mouse-
human approach to develop integrated biomarkers profiles from plasma and plasma exosomes to detect late
precursor stage PanINs prior to development of advanced cancer with subsequent validation for a
prediagnostic biomarker panel. We will also develop a novel two tiered screening strategy with validated
biomarkers and novel imaging tools to change the clinical management plan and significantly improve survival
of one of the most deadly cancers.

## Key facts

- **NIH application ID:** 10450842
- **Project number:** 5U01CA214263-05
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** ANN M KILLARY
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,013,807
- **Award type:** 5
- **Project period:** 2018-08-07 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10450842

## Citation

> US National Institutes of Health, RePORTER application 10450842, Circulating Biomarkers and Imaging for Early Detection of Pancreatic Cancer (5U01CA214263-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10450842. Licensed CC0.

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