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
2 other identifiers
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2020
CompletedFirst Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
April 15, 2026
April 1, 2026
5.7 years
February 4, 2021
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Positive anti-hepatitis C virus (HCV) test result
At baseline
Fibroscan result >= F2
Up to 3 months
Study Arms (1)
Screening (survey, biomarker analysis, fibroscan)
EXPERIMENTALPatients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline.
Interventions
Correlative studies
Undergo fibroscan
Undergo clinical evaluation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica P Hwang
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2021
First Posted
March 8, 2021
Study Start
December 22, 2020
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04