Liver and Intrahepatic Bile Duct CarcinomaNCT04785534
Surveys, Blood Testing, and Fibroscan in Screening for Liver Fibrosis and Liver Cirrhosis
A study testing Clinical Evaluation, Laboratory Biomarker Analysis and Liver Ultrasonographic Elastography in people with Liver and Intrahepatic Bile Duct Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Bile Duct Carcinoma
- What is being tested?
- Clinical Evaluation, Laboratory Biomarker Analysis and Liver Ultrasonographic Elastography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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.
- Being tested
- Clinical Evaluation, Laboratory Biomarker Analysis, Liver Ultrasonographic Elastography, Survey Administration
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical EvaluationOther
Undergo clinical evaluation
Laboratory Biomarker AnalysisOther
Correlative studies
Liver Ultrasonographic ElastographyProcedure or surgery
Also called Fibroscan, TE, Transient Elastography, VCTE
Undergo fibroscan
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Screening (survey, biomarker analysis, fibroscan) | Experimental | Patients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline. Receives: Other: Clinical Evaluation; Other: Laboratory Biomarker Analysis; Procedure: Liver Ultrasonographic Elastography; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start22 Dec 2020
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Bile Duct CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Jessica P Hwang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785534
- Sponsor's protocol ID
- 2019-0978
- Other IDs
- NCI-2021-00214
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Liver Cancer Prevention in the Houston Community Screening for Predictors of Fibrosis and Cirrhosis
- ClinicalTrials.gov ID
- NCT04785534
- Acronym / sponsor ID
- 2019-0978
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (survey, biomarker analysis, fibroscan) | Experimental | Other: Clinical Evaluation, Other: Laboratory Biomarker Analysis, Procedure: Liver Ultrasonographic Elastography, Other: Survey AdministrationPatients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical EvaluationUndergo clinical evaluation | Other | Screening (survey, biomarker analysis, fibroscan) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (survey, biomarker analysis, fibroscan) |
| Liver Ultrasonographic ElastographyAlso: Fibroscan, TE, Transient Elastography, VCTEUndergo fibroscan | Procedure or surgery | Screening (survey, biomarker analysis, fibroscan) |
| Survey AdministrationComplete survey | Other | Screening (survey, biomarker analysis, fibroscan) |
Primary outcome
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.
2 secondary outcomes
Positive anti-hepatitis C virus (HCV) test result
Time frame: At baseline
Fibroscan result >= F2
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- M.D. Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica P Hwang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Evaluation, Laboratory Biomarker Analysis and Liver Ultrasonographic Elastography in people with Liver and Intrahepatic Bile Duct Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive hepatitis B surface antigen test result (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.