Clinical trial NCT04785534: Surveys, Blood Testing, and Fibroscan in Screening for Liver Fibrosis and Liver Cirrhosis
Official title: Patient-Centered Liver Cancer Prevention in the Houston Community Screening for Predictors of Fibrosis and Cirrhosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver and Intrahepatic Bile Duct Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2021-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive hepatitis B surface antigen test result
timeFrame: At baseline
Secondary outcomes:
measure: Positive anti-hepatitis C virus (HCV) test result
timeFrame: At baseline
measure: Fibroscan result >= F2
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jessica P Hwang
role: PRINCIPAL_INVESTIGATOR
References: