'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat' A Prospective Cohort Study Assessing the Impact of Loss to Follow-up on Liver Fibrosis in Chronic Hepatitis C.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Liver Fibrosis Stage
Study Overview
Brief Summary
Objective:
To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.
Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ever diagnosed with hepatitis C, lost to follow-up
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Liver Fibrosis Stage
Time Frame: Baseline
Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness \<7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness \>9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome.
Secondary Outcomes
- Genotype Distribution(Baseline)
- Treatment Outcome(At least 12 weeks after end of treatment)
- Fibrosis Progression(Baseline)
- Reasons for Loss to Follow-up(Baseline)
Investigators
Joost Drenth
Professor, MD, PhD
Radboud University Medical Center