NCT04785534

Surveys, Blood Testing, and Fibroscan in Screening for Liver Fibrosis and Liver Cirrhosis

Patient-Centered Liver Cancer Prevention in the Houston Community Screening for Predictors of Fibrosis and Cirrhosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the use of surveys, blood testing, and fibroscan in screening for liver fibrosis and liver cirrhosis in new or existing patients of the HOPE clinic seeking usual clinical care. Fibroscan is an imaging procedure of the liver which uses a probe like an ultrasound. Information gathered from this study may help researchers learn more about how to prevent or find liver cancer in patients who are currently receiving care at the HOPE clinic. Early detection of liver cancer may improve survival.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the sensitivity of the modified Center for Disease Control (CDC) hepatitis survey in diagnosing chronic hepatitis B virus (HBV) among HOPE clinic patient. SECONDARY OBJECTIVES: I. To estimate the sensitivity of the modified CDC hepatitis survey in identifying chronic active hepatitis C virus (HCV) infection among HOPE clinic patients. II. To estimate the sensitivity of fibrosis serum biomarkers, non-alcoholic fatty liver disease fibrosis score (NFS), fibrosis-4 index (FIB-4), and fatty liver index (FLI) in detecting fibrosis (fibroscan result \>= F2) among HOPE clinic patients with metabolic conditions. III. To estimate the sensitivity of the Alcohol Use Disorder Identification Test Alcohol Consumption (AUDIT-C) in identifying fibrosis (fibroscan result \>= F2) among HOPE clinic patients. IV. To estimate the sensitivity of the AUDIT-10 survey in identifying fibrosis (Fibroscan result \>= F2) among Hope Clinic patients who scored \>= 4 for men or \>= 3 for women on the AUDIT-C. V. To estimate the specificity and accuracy of each of these risk factor screening tools in HOPE clinic patients. VI. To estimate the prevalence of fibrosis and cirrhosis risk factors among HOPE clinic patients. EXPLORATORY OBJECTIVES: I. To explore factors associated with each fibrosis/cirrhosis risk factor. II. To investigate differential diagnostic accuracy of screening methods by fibrosis severity. III. To evaluate the diagnostic performance of each dichotomized biomarker (NFS, FIB-4, and FLI) separately and assess biomarker optimal cutpoints for identifying fibrosis in the study population. OUTLINE: Patients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline. After completion of study, patients are followed up at 3 months.

Conditions

• Liver and Intrahepatic Bile Duct Carcinoma

Interventions

Type	Name	Description
OTHER	Clinical Evaluation	Undergo clinical evaluation
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Liver Ultrasonographic Elastography	Undergo fibroscan
OTHER	Survey Administration	Complete survey

Timeline

• Start date: 2020-12-22
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2021-03-08
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States