# Novel biomarker strategies for HCC early detection in AI/AN patients

> **NIH NIH P20** · UNIVERSITY OF WASHINGTON · 2022 · $155,192

## Abstract

ABSTRACT: PROJECT 1 – Novel Biomarker Strategies
Peripheral blood-based HCC biomarker panels are an essential component of early detection strategies,
especially in remote AI/AN tribal communities and Indian reservations that are very far from any imaging facilities.
Additionally, blood-based biomarker screening achieves greater compliance than imaging-based screening,
even when imaging is readily available.
Promising serum biomarker panels have been undergoing phase 2 and 3 studies of biomarker validation in the
last 5-7 years, such as the GALAD test by Fujifilm-Wako and the methylated DNA marker (MDM) panel by
EXACT Sciences, which raises the possibility of a “liquid biopsy” for early detection of HCC. Unfortunately, none
of these panels have ever been tested in AI/AN patients. It is likely that the performance of these biomarkers will
be significantly different in AI/AN patients than what was described in predominantly Caucasian populations in
whom they were developed.
The overarching aim of Project 1 is to use a translational approach to develop novel biomarker strategies for
early detection of HCC that are designed specifically for AI/AN through 3 interconnected specific aims:
SA1: Determine if hepatocellular carcinoma (HCC) in AI/AN patients is associated with unique or enriched
genomic and/or epigenomic alterations or patterns of alterations compared to other racial/ethnic groups in
order to identify molecular markers, including circulating free methylated DNA (cf mDNA) markers that can be
used for surveillance in AI/AN patients at risk of HCC.
SA2: (Phase 2 study of biomarker development). Perform a case-control study of 100 cases with T1 or T2
HCC (n=50 AI/AN, n=50 other racial/ethnic groups) and 100 at-risk control patients without HCC with cirrhosis
or HBV (n=50 AI/AN, n=50 other racial/ethnic groups) matched by liver disease etiology and cirrhosis severity,
to determine and compare the performance characteristics (sensitivity, specificity, AUROC) of the following
novel HCC screening biomarker panels:
 • Circulating methylated DNA marker (MDM) panel (EXACT sciences)
 • Serum protein-based biomarker panel GALAD (FujiFilm-Wako Diagnostics)
If necessary, we will modify GALAD to optimize its performance for AI/AN persons and consider if its
performance can be further improved by combining it with cf mDNA markers.
SA3: (Phase 3 study of biomarker development). Develop and validate HCC early detection algorithms in an
Alaska cohort of AI/AN patients with HCV-cirrhosis or HBV using longitudinal (serial) AFP or GALAD, or
modified GALAD developed in SA2 specifically for AI/AN patients, modeled by a Parametric Empirical
Bayesian (PEB) and Multivariate Fully Bayesian (mFB) approach.

## Key facts

- **NIH application ID:** 10482367
- **Project number:** 5P20CA252732-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** William Mallory Grady
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $155,192
- **Award type:** 5
- **Project period:** 2021-09-06 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482367

## Citation

> US National Institutes of Health, RePORTER application 10482367, Novel biomarker strategies for HCC early detection in AI/AN patients (5P20CA252732-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10482367. Licensed CC0.

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