Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT04785534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveys, Blood Testing, and Fibroscan in Screening for Liver Fibrosis and Liver Cirrhosis
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Patient-Centered Liver Cancer Prevention in the Houston Community Screening for Predictors of Fibrosis and Cirrhosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-00214 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |