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Precision Risk Stratification and Screening for HCC among Patients with Indeterminate Liver Nodules

不确定肝结节患者的精准风险分层和 HCC 筛查

基本信息

批准号：
10736885
负责人：
Yujin Hoshida
金额：
$ 90.72万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-19 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10736885
关键词：
Abbreviations Abdomen Absenteeism at work Address American Anxiety Benign Biological Markers Biopsy Blood Cancer Etiology Center for Translational Science Activities Cessation of life Cirrhosis Classification Clinical Cohort Studies Complement Data Detection Diagnosis Diagnostic Early Detection Research Network Early Diagnosis Evaluation Facilities and Administrative Costs Funding Goals Harm Reduction Image Infrastructure Lead Literature Liver Liver diseases Magnetic Resonance Imaging Malignant neoplasm of liver Meta-Analysis Methodology Modeling NCI Center for Cancer Research National Cancer Institute Nodule Outcome Patient Recruitments Patients Phase Primary carcinoma of the liver cells Radiation exposure Recommendation Risk Series Serum Site Specific qualifier value Standardization Study models System Testing Validation Variant Work alpha-Fetoproteins biomarker panel biomarker validation blood-based biomarker clinical practice cohort comparative cost effectiveness contrast enhanced cost cost effective cost effectiveness cost-effectiveness evaluation effectiveness evaluation effectiveness validation evidence base experience high risk high risk population imaging biomarker improved individual patient liver cancer model models and simulation novel novel marker patient oriented performance tests personalized care personalized screening precision medicine programs psychologic recruit risk stratification screening surveillance strategy translational cancer research tumor ultrasound

项目摘要

PROJECT SUMMARY Large gaps in current strategies for risk stratification and surveillance contribute to frequent late-stage detection and poor outcomes in patients with hepatocellular carcinoma (HCC). Our Translational Liver Cancer (TLC) Research Center has made important scientific contributions that directly addressed HCC risk stratification and surveillance in patients with cirrhosis. Specifically, we conducted a series of phase II and phase III biomarker studies in patients with cirrhosis to validate 1) the first blood-based biomarker for risk stratification (PLSec-AFP), 2) abbreviated MRI for HCC surveillance, and 3) two biomarker panels, GALAD and Doylestown Plus for HCC surveillance. We also conducted modeling studies to evaluate how these data can be incorporated into clinical practice, evaluating the cost-effectiveness of a precision surveillance strategy in these patients. For our TLC renewal, we leverage our infrastructure and operational expertise to similarly develop an optimized, evidence-based approach to early HCC detection in patients with indeterminate liver nodules (ILNs). Our preliminary data demonstrate that patients with ILNs have an annual HCC risk of 6-10%/year, more than double that of those with cirrhosis without ILNs; however, they experience wide variation in HCC risk and surveillance strategies – with some patients who develop HCC failing to undergo surveillance in the year prior to diagnosis and some patients undergoing repeated CT/MRI-based surveillance despite never developing HCC. Our work highlights the need for accurate risk stratification and surveillance strategies in patients with ILNs to optimize the overall value of early HCC detection programs – gaps that are directly addressed by our proposal. We will leverage our Early Detection Research Network (EDRN)-funded Clinical Validation Center for HCC to efficiently recruit a large cohort of patients with ILNs and (1) validate the effectiveness of a novel biomarker- based risk stratification model, (2) evaluate the effectiveness of surveillance abbreviated MRI and contrast enhanced ultrasound for detecting early-stage HCC, and (3) compare the cost effectiveness of surveillance strategies including a precision screening model in patients with ILNs. Our proposal aligns with the principles of precision medicine and would maximize benefits (via early tumor detection) and minimize harms (via false positive results) for each patient, thereby optimizing the patient- centeredness, cost effectiveness, and overall value of HCC surveillance in patients with ILNs. In addition to our patient cohorts and platform of unique biomarker and imaging data, our TLC research center will contribute methodological expertise in HCC early detection, biomarker validation, and HCC imaging to trans-network projects. Overall, our proposal will transform our approach to early HCC detection in patients with ILNs by validating evidence-based and cost-effective strategies to optimize HCC risk stratification and surveillance.

项目总结