# Clinical Validation Center for Early Detection of Pancreatic Cancer

> **NIH NIH U01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2022 · $737,111

## Abstract

Abstract
Early detection of pancreatic ductal adenocarcinoma (PDAC) is an area of highest priority and an unmet need
for advancing public health in the United States. Certain sub-groups of patients, such as those with germline
mutations, mucinous pancreatic cysts and new-onset diabetes (NOD) are at higher than average risk for PDAC.
In the immediate prior cycle, our EDRN Clinical Validation Center (CVC) at MD Anderson Cancer Center
(MDACC): (a) facilitated the conduct of the first ever, multi-institutional, blinded “biomarker bakeoff” in PDAC by
providing annotated biospecimens, (b) completed one of the first EDRN-defined Phase 3 biomarker studies in
PDAC using pre-diagnostic samples (Fahrmann et al, Gastroenterology 2021), and (c) served as a conduit for
the implementation of additional EDRN collaborative research initiatives, including a pre-diagnostic PDAC
imaging consortium. Our renewal application represents a Gulf Coast-Great Lakes EDRN Clinical Validation
Center (GCGLEC) in Pancreatic Cancer is comprised of UTMDACC/Lyndon B Johnson Hospital (Harris Health,
TX), Henry Ford Health System (HFHS, Detroit, MI) and Ochsner Health System (OHS, New Orleans, LA) and
has three major objectives: First, to implement a multi-institutional framework for collecting the highest quality
biospecimens from patients with a variety of well-defined pancreatic pathologies (including early stage PDAC,
pancreatic cystic lesions, and other benign pancreatic diseases, such as chronic pancreatitis, benign cysts, and
endocrine tumors of low malignant potential), in order to conduct biomarker validation studies for early detection
of PDAC that conform to EDRN-defined Phase 2 and Phase 3 study design. Current PDAC biomarker studies
typically have sparse representation from racial and ethnic minorities, and therefore a major impetus of the
GCGLEC will be to address the “disparity gap” in biomarker research by obtaining biospecimens from
underrepresented minorities. Second, the GCGLEC will build upon our published Phase 3 study utilizing the
“anchor panel” of CA19-9, LRG1 and TIMP-1, by conducting four additional PRoBE-compliant studies that
incorporate autoantibodies, metabolites and additional protein biomarkers for improving the sensitivity of
diagnosing asymptomatic PDAC without compromising the 99% or greater specificity threshold. These EDRN-
defined Phase 3 studies will be conducted in pre-diagnostic cases and controls obtained from existing cohorts,
including the PLCO, WHI, and the so-called “Harvard cohorts” (NHS, PHS, WHS and HPFS), as well as ongoing
prospective cohorts undergoing accrual, such as the NCI-funded New Onset Hyperglcyemia and Diabetes (NOD)
cohort, and the Early detection Initiation (EDI) in PDAC, a collaboration between PanCAN and the NCI. Third,
the GCGLEC will serve as a “hub” for collaborative activities within and outside the EDRN, including
collaborations with investigators funded by the Pancreatic Cancer Detection Consortium (PCDC), and lay...

## Key facts

- **NIH application ID:** 10486389
- **Project number:** 2U01CA200468-06
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** ANIRBAN MAITRA
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $737,111
- **Award type:** 2
- **Project period:** 2016-05-04 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486389

## Citation

> US National Institutes of Health, RePORTER application 10486389, Clinical Validation Center for Early Detection of Pancreatic Cancer (2U01CA200468-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10486389. Licensed CC0.

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