# Development of a panel of multiplex biomarkers for the early detection of pancreatic ductal adenocarcinoma and high-risk lesions

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2024 · $769,085

## Abstract

Pancreatic ductal adenocarcinoma (PDAC) is an extremely aggressive malignancy with an overall 5-year survival
of 11%. Due to its asymptomatic nature and lack of methods for early detection, the majority of PDAC patients
(> 85%) present with non-localized tumors. This highlights the need to detect PDAC at an earlier, localized stage.
Intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN) offer a unique
opportunity to identify premalignant lesions to serve as targets for early detection strategies. Dr. Randall Brand
and others proposed a two-step surveillance approach for early detection of PDAC: 1) identification of high-risk
populations through clinical evaluation with an elevated PDAC prevalence close to or above 1% and 2)
development of serum biomarker(s), for repeated testing at intervals to detect subjects in surveillance with a
rising risk of PDAC (prevalence ~ 10%) for additional imaging. The goal of this proposal is to identify serum
biomarkers and develop in vitro diagnostic multivariate index assays (IVDMIAs) and incorporate them into an
“early detection through surveillance” workflow for the detection of early-stage PDAC and its precursor lesions.
The intended use of these IVDMIAs are 1) to assist in the clinical evaluation of high-risk subjects to be included
in surveillance for the early detection of PDAC, and 2) to detect rising risk of PDAC or high-risk IPMN in the
longitudinal evaluation of subjects in surveillance. The project has five specific aims: 1. To discover and develop
serum-based PDAC early detection biomarkers through integrated proteomic analysis of serum/tissue samples
from early-stage PDAC, IPMN, and benign and healthy controls using a multimodal and phased approach with
corroborative supporting evidence from tissue-based proteomic analysis and immunohistochemical (IHC)
verification. 2. To use a by-design approach driven by predefined intended uses that are both clinically
meaningful and practically feasible to develop and evaluate serum biomarkers for IVDMIAs. 3. To develop and
optimize multiplex analytical assays for selected biomarkers and apply them to generate high-quality biomarker
data for IVDMIA development and clinical evaluation. 4. To collect and assemble large clinical specimen sample
sets for both IVDMIA algorithm development and independent validation. 5. To participate in collaborative
activities with other PCDC-RUs. To be successful, the proposed project requires a multi-disciplinary, systems
approach and the support of critical technology, data science, and clinical specimen resources. Our team is a
unique ensemble of experts in PDAC and IPMN pathology for early detection, clinical chemistry/assay
development, clinical proteogenomics, and statistical/machine learning for IVDMIA development. Most
importantly, the team members individually and collectively all have a long-standing history of active research
with accomplishments in biomarker development and translation into c...

## Key facts

- **NIH application ID:** 10890753
- **Project number:** 5U01CA274514-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Randall Brand
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $769,085
- **Award type:** 5
- **Project period:** 2023-07-19 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10890753

## Citation

> US National Institutes of Health, RePORTER application 10890753, Development of a panel of multiplex biomarkers for the early detection of pancreatic ductal adenocarcinoma and high-risk lesions (5U01CA274514-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10890753. Licensed CC0.

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