'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Study Overview
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Brief Summary
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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of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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.

Official Title
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'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.

Conditions
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Chronic Hepatitis c

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ever diagnosed with hepatitis C, lost to follow-up Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lost to follow-up patients<br>This so-called lost population consists of all patients, that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Fibrosis Stage | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for Loss to Follow-up | through chart review or questioning screening event | Baseline | 
| Genotype Distribution | Genotype distribution among RNA-positive patients | Baseline | 
| Fibrosis Progression | Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation. | Baseline | 
| Treatment Outcome | Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment | At least 12 weeks after end of treatment |