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

美国肝硬化患者的 HCC 精准风险分层和筛查

基本信息

批准号：
10225536
负责人：
Amit Singal
金额：
$ 70.17万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-14 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10225536
关键词：
Abdomen Biological Markers Blinded Blood Body mass index Cause of Death Center for Translational Science Activities Characteristics Cirrhosis Cohort Studies Complement Data Data Set Detection Diagnosis Early Detection Research Network Early Diagnosis Etiology Evaluation Funding Goals Heterogeneity Image Individual Liver diseases Magnetic Resonance Imaging Michigan Modeling Molecular Profiling Patients Performance Primary carcinoma of the liver cells Professional Organizations Prognosis Prospective cohort Protocols documentation Public Health Quality-Adjusted Life Years Risk Risk Factors Role Serum Severities Severity of illness Subgroup Testing Texas Ultrasonography United States Universities alpha-Fetoproteins base biomarker panel biomarker performance case control clinical risk cohort comparative cost effectiveness compare effectiveness contrast enhanced cost effective cost effectiveness curative treatments design early detection biomarkers effectiveness testing high risk imaging biomarker improved individual patient models and simulation mortality novel patient population performance tests personalized screening precision medicine prospective risk stratification sample collection screening sex standard of care tumor

项目摘要

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

项目摘要/摘要