Genotype and Subtype Mapping of the Hepatitis C Virus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Chronic hepatitis C virus (HCV) infection is the second leading cause of primary liver cancer worldwide and the leading cause in the United States. In 2020, an estimate 260,000 deaths were attributable to HCV globally, nearly 80,000 of which occurred in Europe, mainly due to complications such as cirrhosis or hepatocellular carcinoma (HCC).
The CARTO-VHC study is a retrospective, observational, multicenter study based on data and samples collected during routine care from 2023 to 2024. The study does not involve direct human participation. The study aims to describe the different genotypes and subtypes of the hepatitis C virus, including unusual subtypes, in a large population of newly diagnosed HCV-positive patients. This will help identify the most common types circulating in France. Additionally, the study will provide a comprehensive understanding of therapeutic failures and drug resistance to direct-acting antivirals (DAA) in treated patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 years old or more
Newly diagnosed patient positive for HCV (presence of HCV antibodies)
Patient with active infection (HCV RNA > 0)
Disqualifiers
Patients who decline to participate in the study and oppose the use of their personal data
Patients under legal protection (guardianship or curatorship)
Trial population
Defined population
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.
Time frame
1st yearSecondary outcomes
1
Proportion of patients with cirrhosis
Time frame
last 6 month of 1st year2
Proportion of patients infected with an "unusuel" subtype
Time frame
1st 6 month of 3rd year3
Proportion of viruses carrying polymorphisms in the NS3, NS5A, and/or NS5B genes among the "unusuel" subtypes
Time frame
Last 6 month of 2nd year and first 6 month of 3rd year4
Proportion of patients with treatment failure
Time frame
Trim 2 and trim 3 of 3rd yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: