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The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study

NCT01831037 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-01-28

No results posted yet for this study

Summary

This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB) experiencing regression of liver cirrhosis after effective antiviral therapy have decreased risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

Conditions

Interventions

OTHER

Regression of fibrosis

Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (\>50% of cases).

OTHER

Specific risk factors related to hepatocellular carcinoma

Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Andres Duarte-Rojo, MD, MSc · University of Arkansas

  • Jonathan A Dranoff, MD · University of Arkansas

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831037 on ClinicalTrials.gov