# Clinical Validation Center for Hepatocellular Carcinoma

> **NIH NIH U01** · UT SOUTHWESTERN MEDICAL CENTER · 2022 · $787,434

## Abstract

PROJECT SUMMARY
Hepatocellular carcinoma (HCC) is one of the fastest-growing cause of cancer death in the U.S. and it is
projected to be the 3rd leading cause of cancer death in the U.S. by 2040 given the poor effectiveness of current
HCC risk stratification and early detection strategies. Specifically, HCC screening is recommended in all patients
with cirrhosis, despite annual HCC risk varying between 1-4%/year, highlighting a need for risk stratification
biomarkers. HCC screening is performed using abdominal ultrasound and the serum biomarker alpha fetoprotein
(AFP); however, this strategy misses over one-third of HCCs at an early stage and results in screening harms in
many patients. The goal of our Clinical Validation Center for HCC (CVC-HCC) is to validate novel blood and
imaging biomarkers in phase I-III studies to improve HCC risk stratification and early detection.
Translation of HCC biomarkers to practice has been hampered by a dearth of high-quality sample sets including
both stored blood and imaging. Existing sample sets also primarily include patients with cirrhosis from active
viral hepatitis, with limited applicability to contemporary populations who primarily have cured viral hepatitis or
non-viral causes of liver disease. Our CVC will create a contemporary resource with blood and imaging data to
allow for rapid validation of promising biomarkers for HCC risk-stratification and early detection in phase I-III
studies. A specific population in need of better biomarkers is patients with indeterminate liver nodules (ILNs) on
diagnostic CT or MRI, which are observed in over one-fourth of patients undergoing HCC screening and have a
high, yet variable, risk for developing into HCC (annual risk ~6-10%/year). Our group has validated a novel blood-
based biomarker, PLSec, for risk stratification and a biomarker panel, GALAD, for early HCC detection in patients
with cirrhosis and herein propose to perform a phase II-III biomarker study to evaluate them in patients with ILNs.
Our team includes national leaders in HCC screening, imaging, and biomarker validation. We are leading efforts
to evaluate HCC biomarkers including the EDRN-funded Hepatocellular Early Detection Strategy (HEDS) Study,
NCI-funded Translational Liver Cancer (TLC) Consortium, and CPRIT-funded Texas HCC Consortium. We will
leverage existing infrastructure across five health systems to create two novel resources not offered by the
current sample sets including (1) a biorepository with both blood and imaging data from patients, with and without
HCC, representing contemporary etiologies of liver disease for Phase II studies and (2) a prospective cohort of
patients with ILNs to evaluate HCC risk stratification and early detection biomarkers in Phase III studies using a
prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design. We will work with the BCCs
and DMCC to evaluate novel biomarkers, facilitating contributions to trans-network projects. Overall, ou...

## Key facts

- **NIH application ID:** 10486296
- **Project number:** 1U01CA271887-01
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** FASIHA KANWAL
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $787,434
- **Award type:** 1
- **Project period:** 2022-08-03 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486296

## Citation

> US National Institutes of Health, RePORTER application 10486296, Clinical Validation Center for Hepatocellular Carcinoma (1U01CA271887-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10486296. Licensed CC0.

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