# Circulating Biomarkers and Imaging for Early Detection of Pancreatic Cancer

> **NIH NIH U01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2024 · $799,728

## Abstract

Abstract
The overall goal of this renewal application is to validate biomarker signatures associated with aberrantly
expressing pathways in pancreatic cancer for early stage PDAC detection among asymptomatic patients with
high risk clinical, genetic and/or familial susceptibility characteristics. PDAC early detection signatures,
developed with circulating transcriptomics, proteomics and metabolomics (omics) biomarkers identified in the
first funding cycle, will be characterized for their association with heterogeneous disease subtypes and integrated
with imaging-based disease subtype features derived with machine learning methods from CT/MRI scans
reflecting functional changes in malignant lesions of the pancreas. Integration of Omics data with CT imaging
features will be done by developing Multimodal Integrative Analytical Models (MIAM) predictive of early
stage pancreatic cancer. Together, the pathway-based biomarker panels integrated with CT imaging data will
define a novel clinically significant strategy for early detection and risk stratification. During the first funding cycle,
a number of omics based circulating biomarkers were developed and validated in multiple sample cohorts from
patients with early stage resectable disease. These together with additional candidate biomarkers in the pipeline
will be further validated and investigated for their association with disease subtypes in Phases II, III and IV
studies according to PRoBE-design in the renewal application. For phase IV studies, performance of the
biomarkers in detecting disease and predicting clinical outcomes among asymptomatic patients and at-risk
individuals will be ascertained with retrospective and prospective longitudinal pre-diagnostic sample cohorts,
including one representing the underserved population. The innovative statistical approach of MIAM will be
shared with other members of the consortia for rigorous validation and in the long term, we hope to translate the
findings into developing open source software for use in clinical diagnostic laboratories in the future.
Specific Aims of the PCDC grant are:
Aim 1: Validation of pathway-associated biomarker signatures and novel CT imaging features for
molecular subtype-related early stage PDAC and development of MIAM to integrate approaches for
detection of early stage PDAC in Phase II cohorts.
Aim 2: Validation of circulating Omics biomarkers and integration with precision imaging features in
Phase III retrospective longitudinal pre-diagnostic cohorts for early detection and risk assessment.
Aim 3: Prospective Screening and Validation of biomarker panels in Phase IV High Risk Cohorts-
Aim 4: Participate in collaborative projects with other PCDC-RUs by sharing data/ideas and contribute
in building biorepository and assay development using our unique technical and a

## Key facts

- **NIH application ID:** 10864325
- **Project number:** 2U01CA214263-06
- **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:** 2024
- **Award amount:** $799,728
- **Award type:** 2
- **Project period:** 2018-08-07 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10864325

## Citation

> US National Institutes of Health, RePORTER application 10864325, Circulating Biomarkers and Imaging for Early Detection of Pancreatic Cancer (2U01CA214263-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10864325. Licensed CC0.

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