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

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ClinicalTrials.gov Identifier: NCT04785534
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : June 9, 2022
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Liver and Intrahepatic Bile Duct Carcinoma Other: Clinical Evaluation Other: Laboratory Biomarker Analysis Procedure: Liver Ultrasonographic Elastography Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Patient-Centered Liver Cancer Prevention in the Houston Community Screening for Predictors of Fibrosis and Cirrhosis
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024


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: Clinical Evaluation
Undergo clinical evaluation

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Liver Ultrasonographic Elastography
Undergo fibroscan
Other Names:
  • Fibroscan
  • TE
  • Transient Elastography
  • VCTE
  • Vibration-Controlled Transient Elastrography

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  1. Positive hepatitis B surface antigen test result [ Time Frame: At baseline ]
    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.


Secondary Outcome Measures :
  1. Positive anti-hepatitis C virus (HCV) test result [ Time Frame: At baseline ]
    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.

  2. Fibroscan result >= F2 [ Time Frame: Up to 3 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785534


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jessica P. Hwang    713-745-4516    jphwang@mdanderson.org   
Principal Investigator: Jessica P. Hwang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cancer Prevention Research Institute of Texas
Investigators
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Principal Investigator: Jessica P Hwang M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04785534    
Other Study ID Numbers: 2019-0978
NCI-2021-00214 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary