# Precision Risk Stratification and Screening for HCC among Patients with Cirrhosis in the United States

> **NIH NIH U01** · UT SOUTHWESTERN MEDICAL CENTER · 2021 · $701,712

## Abstract

PROJECT SUMMARY / ABSTRACT
Hepatocellular carcinoma (HCC)-related mortality in the U.S. is rapidly rising. Given the association between
early detection and improved survival, screening using ultrasound +/- a serum biomarker, alpha fetoprotein
(AFP), is recommended in at-risk individuals, including all patients with cirrhosis. However, most HCC patients
are diagnosed at a late stage due to limitations in this strategy. Specifically, the strategy of ultrasound and AFP
in all cirrhosis patients is inadequate because it ignores: 1) heterogeneity in risk between patients; 2) the poor
accuracy of screening tests; and 3) the poor reliability of screening test performance between patients. The
current “one-size-fits-all” approach to HCC screening leads to over-screening of low-risk cirrhosis patients and
under-screening of high-risk patients, diluting the overall value of HCC screening.
Our proposal's goal is to develop and evaluate a precision screening strategy for early stage HCC in patients
with cirrhosis that matches the best screening tests to individual risk and screening test performance. We will
leverage five patient populations (4 prospective cohorts and one case-control dataset) with a total of >6000
cirrhosis patients to evaluate and compare biomarker- and imaging-based models for HCC risk stratification
and early detection. Specifically, we propose to:
Aim 1: Validate and compare the performance of two risk stratification models to stratify cirrhosis patients with
 low-, intermediate- and high-risk of developing HCC
Aim 2: Evaluate the performance of an abbreviated MRI protocol +/- serum biomarkers (including AFP, AFP-
 L3, and DCP) vs. ultrasound +/- serum biomarkers for early HCC detection in patients with cirrhosis
Aim 3: Compare the cost effectiveness, using micro-simulation modeling, of a tailored screening strategy
 based on individual HCC risk and expected screening test performance to the current standard strategy of
 ultrasound and AFP in all patients with cirrhosis
Our proposal leverages 5 distinct patient populations with >6000 cirrhosis patients, to compare biomarker- and
imaging-based models for HCC risk stratification and early detection. We use these data to compare the
effectiveness of a tailored screening strategy to the current strategy of ultrasound and AFP for all patients
using micro-simulation modeling. Tailoring HCC screening efforts to individual risk and screening test
performance moves beyond the current “one-size-fits-all” strategy and aligns HCC screening with the principles
of precision medicine. Our proposed HCC screening strategy would maximize screening benefits and minimize
screening harms for each patient, thereby optimizing overall HCC screening value in the United States.
2

## Key facts

- **NIH application ID:** 10225536
- **Project number:** 5U01CA230694-04
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Amit Singal
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $701,712
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10225536

## Citation

> US National Institutes of Health, RePORTER application 10225536, Precision Risk Stratification and Screening for HCC among Patients with Cirrhosis in the United States (5U01CA230694-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10225536. Licensed CC0.

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