Chronic Hepatitis c
Conditions
Brief summary
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
Interventions
None listed
Sponsors
Gilead Sciences
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test * Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result
Exclusion criteria
* Younger than 18 * Deceased * Not residing in the Netherlands * Unknown current address * Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of lost to follow-up (LTFU) patients successfully re-linked to care | End of study, on average 2.5 years after initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Case ascertainment rate | End of study, on average 2.5 years after initiation | Established contact (via telephone or in writing) with a patient who is eligible for retrieval |
| Awareness of HCV diagnosis among LTFU patients | End of study, on average 2.5 years after initiation | Number of patients who were aware of their HCV diagnosis when they are invited for re-evaluation |
| Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test | End of study, on average 2.5 years after initiation | — |
| Number of viraemic patients at time of re-evaluation | End of study, on average 2.5 years after initiation | — |
| Total number of LTFU patients in the investigated time period | 15 years prior to study initiation | — |
| Reasons for becoming LTFU | End of study, on average 2.5 years after initiation | — |
| Time of being LTFU | End of study, on average 2.5 years after initiation | Defined as years since last (HCV-)related hospital visit |
| Mode of HCV transmission | End of study, on average 2.5 years after initiation | — |
| Sustained virological response | End of study, on average 2.5 years after initiation | Defined as the absence of HCV RNA at least 12 weeks after treatment |
| Liver fibrosis stage of retrieved patients | End of study, on average 2.5 years after initiation | — |
Countries
Netherlands
Contacts
Primary ContactMarleen van Dijk, MD
Outcome results
None listed