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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver and Intrahepatic Bile Duct Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Survey Administration; Other: Clinical Evaluation; Procedure: Liver Ultrasonographic Elastography

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be at least 18 years old
• Must be a new or existing patient of the HOPE clinic seeking usual clinical care
• Must be able to speak and read English or a language other than English for which there is a translator available on site at the HOPE clinic

Exclusion Criteria:

• Known pregnancy at time of recruitment. The HOPE clinic will ask the female patients if they are pregnant, will ask the participants for their last menstrual period (LMP), and/or they will use the urine pregnancy test (UPT) results in their electronic medical records

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening (survey, biomarker analysis, fibroscan); Patients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Survey Administration; Complete survey; Other: Clinical Evaluation; Undergo clinical evaluation; Procedure: Liver Ultrasonographic Elastography; Undergo fibroscan; Other Names: Fibroscan; TE; Transient Elastography; VCTE; Vibration-Controlled Transient Elastrography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive hepatitis B surface antigen test result	The presence of at least one risk factor for hepatitis B virus (HBV) on the screening questionnaire will indicate a positive (versus negative) screening for HBV infection.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive anti-hepatitis C virus (HCV) test result	Will assess positive anti-HCV test result AND either 1) detectable HCV ribonucleic acid, or 2) history of HCV infection and past anti-HCV treatment. Will estimate the prevalence and exact binomial 95% confidence intervals for each of the fibrosis and cirrhosis risk factors examined in this study. For each risk factor, we will first present a cross tabulation of the dichotomous screening test result by the dichotomous gold standard result. To evaluate the performance of each screening method, will calculate point estimates and 95% confidence intervals for the sensitivity, specificity, likelihood ratio, and diagnostic odds ratio.	At baseline
Fibroscan result >= F2	Will estimate the prevalence and exact binomial 95% confidence intervals for each of the fibrosis and cirrhosis risk factors examined in this study. For each risk factor, we will first present a cross tabulation of the dichotomous screening test result by the dichotomous gold standard result. To evaluate the performance of each screening method, will calculate point estimates and 95% confidence intervals for the sensitivity, specificity, likelihood ratio, and diagnostic odds ratio.	Up to 3 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Jessica P Hwang, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal
• Other Study ID Numbers: 2019-0978; NCI-2021-00214 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No