# Biomarker validation for intraductal papillary mucinous neoplasms of the pancreas

> **NIH NIH R01** · DUKE UNIVERSITY · 2024 · $386,483

## Abstract

PROJECT SUMMARY/ABSTRACT: Intraductal papillary mucinous neoplasms (IPMN) of the
pancreas are cystic tumors that represent a radiographically identifiable precursor lesion of
pancreatic cancer. Currently, IPMN represent our best opportunity for intervention - and
interception - prior to the development of an incurable cancer. The challenge however, is current
laboratory, endoscopic, and imaging technologies are unable to distinguish between IPMN that is
at low-risk (low-grade dysplasia) or at high-risk (high-grade dysplasia) of becoming an invasive
cancer. In addition, our ability to improve diagnostic accuracy - particularly through biomarker
development - has been difficult, as IPMN is very heterogeneous with multiple histologic sub-
types and grades of dysplasia existing within the same lesion. Over the past 18 months we have
designed and performed pilot studies utilizing a novel spatial transcriptomics platform as a means
to spatially identify precise, sub-type specific, epithelial markers of high-grade dysplasia in the
tissue from patients resected for IPMN. These studies have found significant differences in gene
expression between both low-grade and high-grade dysplasia - and for the first time - have clearly
defined gene expression differences between intestinal and pancreaticobiliary sub-type IPMN.
The importance of this latter finding cannot be overemphasized, as intestinal sub-type IPMN will
typically progress to invasive colloid cancer, which is a much less aggressive malignancy.
Furthermore, we have identified differences in cyst fluid protein abundances between intestinal
and pancreaticobiliary sub-type IPMN that mirror these gene expression differences. In this
project, we will utilize this spatial platform to expand our work and identify sub-type specific
epithelial markers of high-grade dysplasia. We will then assess cyst fluid for these proteins using
a novel proteomics platform (Olink Focus), and further develop a prediction model for high-risk
disease (validated during the previous project period, AUC approximately 0.8). Finally, we will
attempt to rapidly validate this model(s) by applying the model(s) to two separate cyst fluid
repositories developed by our group that contain cyst fluid from hundreds of patients who have
been managed for pancreatic cysts - and have mature follow-up. We believe this approach will
allow us to identify very specific cyst fluid protein markers to both epithelial sub-type and grade of
dysplasia and develop a very accurate test for high-risk IPMN. Patients with IPMN represent a
population in which the identification of accurate markers of high-grade dysplasia will allow for
curative intervention (resection) prior to the development of an incurable disease, while sparing
those with low-grade lesions the morbidity – and even mortality – of operation.

## Key facts

- **NIH application ID:** 10893601
- **Project number:** 5R01CA182076-07
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Peter J Allen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $386,483
- **Award type:** 5
- **Project period:** 2014-09-01 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10893601

## Citation

> US National Institutes of Health, RePORTER application 10893601, Biomarker validation for intraductal papillary mucinous neoplasms of the pancreas (5R01CA182076-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10893601. Licensed CC0.

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