Clinical validation center for hepatocellular carcinoma

Active Cooperative Agreement Awarded Last action

Award ID
U01CA271887
Recipient
Awarding agency
Obligated
$4,734,180

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date 86% complete
Place of performance
Dallas, TX 75390, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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, our CVC- HCC will lead to significant advances in phase I-III validation of novel biomarkers for HCC risk stratification and early detection, areas of need that will facilitate development of well-designed phase IV clinical utility trials.

Transactions

Action Obligated Date
Amendment $1,003,597
Amendment $0
Amendment $0
Amendment Clinical validation center for hepatocellular carcinoma - hepatocellular carcinoma (HCC) is one of the fastest-growing cause of cancer death in the U.S. And… $893,833
Amendment $1,007,940
Amendment $1,041,376
Amendment $0
Original award $787,434

Subawards

Subrecipient Amount Awarded
Baylor College Of Medicine Dr. Kanwal will be responsible for following activities as part of this scope of work: 1. Identification, enrollment, and follow-up of eligible patients with… $684,370
Regents Of The University Of Michigan Will aid in identifying, enrolling and following up of eligible patients for chronic liver disease $667,312
Dana-Farber Cancer Institute, Inc. Evaluate biomarkers of risk prediction and early detection, develop risk prediction model and early detection screening algorithms, and report results. $34,083
The Trustees Of The University Of Pennsylvania Will aid in identifying, enrolling and following up of eligible patients for chronic liver disease $548,059

Quick answers

Who received award U01CA271887?

U01CA271887 was awarded to The University Of Texas Southwestern Medical Center by National Cancer Institute (National Institutes of Health) on August 3, 2022.

How much is award U01CA271887 worth?

$4,734,180 has been obligated on U01CA271887.

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