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Clinical Validation Center for Hepatocellular Carcinoma

肝细胞癌临床验证中心

基本信息

批准号：
10676320
负责人：
FASIHA KANWAL
金额：
$ 104.14万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-03 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10676320
关键词：
Abdomen Area Biological Markers Blinded Blood Cancer Etiology Cessation of life Cirrhosis Clinical Data Detection Development Diagnostic Early Detection Research Network Early Diagnosis Effectiveness Etiology Evaluation Funding Future Goals Guidelines Health system Heterogeneity Image Infrastructure Liver Liver diseases Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of liver Modeling Molecular Profiling Nodule Patients Performance Phase Policies Population Primary Malignant Neoplasm of Liver Primary carcinoma of the liver cells Prospective cohort Radiology Specialty Recommendation Resources Risk Risk Factors Sampling Serum Testing Texas Translations Validation Viral hepatitis Work alpha-Fetoproteins biobank biomarker discovery biomarker panel biomarker validation blood-based biomarker clinical practice clinical risk cohort curative treatments design early detection biomarkers ethnic minority high risk imaging biomarker imaging study improved novel novel marker patient population patient stratification phase 2 study phase 3 study prospective racial minority radiological imaging radiomics risk stratification sample collection screening tumor ultrasound validation studies

项目摘要

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, 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.

项目总结