# Precision Risk Stratification and Screening for HCC among Patients with Indeterminate Liver Nodules

> **NIH NIH U01** · UT SOUTHWESTERN MEDICAL CENTER · 2024 · $846,605

## Abstract

PROJECT SUMMARY
Large gaps in current strategies for risk stratification and surveillance contribute to frequent late-stage detection
and poor outcomes in patients with hepatocellular carcinoma (HCC). Our Translational Liver Cancer (TLC)
Research Center has made important scientific contributions that directly addressed HCC risk stratification and
surveillance in patients with cirrhosis. Specifically, we conducted a series of phase II and phase III biomarker
studies in patients with cirrhosis to validate 1) the first blood-based biomarker for risk stratification (PLSec-AFP),
2) abbreviated MRI for HCC surveillance, and 3) two biomarker panels, GALAD and Doylestown Plus for HCC
surveillance. We also conducted modeling studies to evaluate how these data can be incorporated into clinical
practice, evaluating the cost-effectiveness of a precision surveillance strategy in these patients.
For our TLC renewal, we leverage our infrastructure and operational expertise to similarly develop an optimized,
evidence-based approach to early HCC detection in patients with indeterminate liver nodules (ILNs). Our
preliminary data demonstrate that patients with ILNs have an annual HCC risk of 6-10%/year, more than double
that of those with cirrhosis without ILNs; however, they experience wide variation in HCC risk and surveillance
strategies – with some patients who develop HCC failing to undergo surveillance in the year prior to diagnosis
and some patients undergoing repeated CT/MRI-based surveillance despite never developing HCC. Our work
highlights the need for accurate risk stratification and surveillance strategies in patients with ILNs to optimize the
overall value of early HCC detection programs – gaps that are directly addressed by our proposal.
We will leverage our Early Detection Research Network (EDRN)-funded Clinical Validation Center for HCC to
efficiently recruit a large cohort of patients with ILNs and (1) validate the effectiveness of a novel biomarker-
based risk stratification model, (2) evaluate the effectiveness of surveillance abbreviated MRI and contrast
enhanced ultrasound for detecting early-stage HCC, and (3) compare the cost effectiveness of surveillance
strategies including a precision screening model in patients with ILNs.
Our proposal aligns with the principles of precision medicine and would maximize benefits (via early tumor
detection) and minimize harms (via false positive results) for each patient, thereby optimizing the patient-
centeredness, cost effectiveness, and overall value of HCC surveillance in patients with ILNs. In addition to our
patient cohorts and platform of unique biomarker and imaging data, our TLC research center will contribute
methodological expertise in HCC early detection, biomarker validation, and HCC imaging to trans-network
projects. Overall, our proposal will transform our approach to early HCC detection in patients with ILNs by
validating evidence-based and cost-effective strategies to optimize HCC risk st...

## Key facts

- **NIH application ID:** 10931647
- **Project number:** 5U01CA283935-02
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Yujin Hoshida
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $846,605
- **Award type:** 5
- **Project period:** 2023-09-19 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10931647

## Citation

> US National Institutes of Health, RePORTER application 10931647, Precision Risk Stratification and Screening for HCC among Patients with Indeterminate Liver Nodules (5U01CA283935-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10931647. Licensed CC0.

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