# Precision Screening for Hepatocellular Carcinoma in Patients with Cirrhosis

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 2021 · $214,141

## Abstract

PROJECT SUMMARY / ABSTRACT
The mortality of hepatocellular carcinoma (HCC) is rising, and it is projected to become the 3rd leading cause of
cancer death in the U.S. by 2030. Given the association between early tumor detection and improved survival,
multiple national professional societies recommend screening using abdominal ultrasound with or without a
serum biomarker, alpha fetoprotein (AFP), every 6 months in at-risk individuals, including all patients with
cirrhosis. However, most HCC patients are diagnosed at a late stage due to limitations in our current early
detection strategy. The strategy of ultrasound and AFP for all cirrhosis patients is inadequate for 3 reasons: 1)
It ignores heterogeneity in HCC risk between cirrhosis patients; 2) It ignores the poor accuracy of current
screening tests; and 3) It ignores poor reliability of screening test performance between patients.
Our proposal’s goal is to develop and evaluate a precision medicine strategy for early HCC detection in
patients with cirrhosis that matches the best screening test to individual risk and screening test performance.
We will leverage prospective cohort studies among 2000 patients with cirrhosis to evaluate the performance of
risk stratification and early detection models incorporating novel biomarkers. Specifically, we propose to:
Aim 1: Develop and validate the performance of risk stratification models incorporating a blood-based
 molecular signature panel to risk stratify cirrhosis patients for developing HCC
Aim 2: Characterize and compare the performance of two biomarker-based early HCC detection strategies,
 the Doylestown Plus and a longitudinal biomarker algorithm, in a diverse cohort of patients with cirrhosis
Aim 3: Compare the cost effectiveness, using micro-simulation modeling, of a tailored early detection 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 two prospective cohort studies with 2000 cirrhosis patients, to evaluate novel
biomarker-based models for HCC risk stratification and early detection. We use these data to compare the
effectiveness of a tailored early detection strategy to the current strategy of ultrasound and AFP for all patients
using micro-simulation modeling. Tailoring early HCC detection 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 early detection strategy would maximize screening benefits and
minimize screening harms for each patient, thereby optimizing HCC screening value in the United States.

## Key facts

- **NIH application ID:** 10120644
- **Project number:** 5R01CA222900-04
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Amit Singal
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $214,141
- **Award type:** 5
- **Project period:** 2018-01-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10120644

## Citation

> US National Institutes of Health, RePORTER application 10120644, Precision Screening for Hepatocellular Carcinoma in Patients with Cirrhosis (5R01CA222900-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10120644. Licensed CC0.

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