# Biomarker Validation in Pancreatic Cystic Neoplasms

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $820,061

## Abstract

Project Summary
Pancreatic cystic neoplasm (PCN) represents a common incidental finding in the population. Branch-duct
intraductal papillary mucinous neoplasms (IPMN), the most common incidentally discovered PCN, have a risk of
malignancy approaching 15%within 15 years of diagnosis. The performance of existing guidelines for identifying
early cancer is poor, and results in both surgical overtreatment and missed opportunities for early diagnosis.
Effective screening biomarkers are needed to accurately differentiate high-risk PCN that require close
surveillance from low risk lesions with little chance to progress.
In this proposal, we will test and validate of three novel blood-based biomarkers and one cyst fluid biomarker for
the detection of early PDAC in patients with PCN. The proposed markers, developed in both academic and
industry settings, show promise in preliminary studies, with sensitivity and specificity sufficiently high to warrant
further evaluation. We will incorporate prospective-specimen-collection, retrospective-blinded-evaluation
(PRoBE) standards to rigorously test the performance of these biomarkers with samples collected from three
cohorts: 1) stage I/II PDAC and controls; 2) Patients with PCN who undergo surgical resection; 3) Patients with
PCN ≥ 2.5 cm or main pancreatic duct ≥ 5 mm under surveillance with serial imaging and sample collection. We
will test performance of the biomarkers individually, and as part of multi-variable models in combination with
each other, with the added information of germline testing and clinical laboratory values (CA19 -9, HbA1c), and
with specific PDAC risk factors (smoking status, alcohol consumption, diabetes, pancreatitis history).
Key components of our research strategy to tackle this recalcitrant problem include: 1) rigorous testing of several
promising blood-based biomarkers, individually and in combination, through a unique collaboration between
industry and academic partners; 2) testing of a novel platform for advanced cyst fluid analysis for early detection
of PDAC and comparison of its performance to blood-based biomarkers; 3) a large number of retrospective and
prospective samples interrogated using the PRoBE design, with statistical rigor for biomarker validation; 4)
resources leveraged from the established Pancreatic Cancer Early Detection (PRECEDE) Consortium including
standardized collection of germline genetic testing, clinical, and laboratory data with blood and cyst fluid
biosampling in accordance with PCDC protocols; 6) collection of a large set of de-identified partnering pancreatic
images (MRI/MRCP, CT and EUS) and digitized pathology slides on a funded cloud-based platform for
collaborative opportunities using artificial intelligence and machine learning strategies, and 7) multimodal data
integration for model development. Longitudinal biospecimens will be shared with the PCDC to support the
Signature Cohorts, and de-identified stored images (MRI, EUS, digitized pathology)...

## Key facts

- **NIH application ID:** 11170341
- **Project number:** 7U01CA282272-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Jessica Everett
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $820,061
- **Award type:** 7
- **Project period:** 2023-09-15 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11170341

## Citation

> US National Institutes of Health, RePORTER application 11170341, Biomarker Validation in Pancreatic Cystic Neoplasms (7U01CA282272-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11170341. Licensed CC0.

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