Genotype and Subtype Mapping of the Hepatitis C Virus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatitis C Virus, Mutation Abnormality, RNA Positive, Unusual Subtype. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cartographie Des génotypes et Sous-types du Virus de l'hépatite C
Overview
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.
Detailed description
The study will consist of the following:
1. Inclusion of patients who meet the selection criteria (hospitalized patients and outpatients from tertiary centers in mainland France) ; 2. Collecting all associated data, including demographic, clinical, and therapeutic information. A Clinical research technician may be assigned to centers lacking sufficient human resources; 3. Collect leftover patient specimens for viral genotyping (phylogenetic analysis of a portion of the NS5B gene, the reference method) or complete genome sequencing of unusual subtypes; 4. Perform molecular biology genotyping techniques (RNA extraction, PCR, and Sanger sequencing of a portion of the NS5B gene); 5. Carry out next-generation sequencing (Seq2000, Illumina) of the full genome of "unusual" subtype strains, or DAAs resistant patients 6. Analyze genotype and subtype information, as well as its correlation with demographic, clinical, and therapeutic data.
Primary outcome measures
- Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations. [Time frame: 1st year]
Secondary outcome measures (6)
- Proportion of patients with cirrhosis [Time frame: last 6 month of 1st year]
- Proportion of patients infected with an "unusuel" subtype [Time frame: 1st 6 month of 3rd year]
- 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 year]
- Proportion of patients with treatment failure [Time frame: Trim 2 and trim 3 of 3rd year]
- Proportion of RAS (resistance-associated substitutions) in the regions targeted by DAAs among patients with treatment failure, according to the HCV genotype [Time frame: Last 6 month of 3rd year]
- Proportion of patients born in Asia and Africa [Time frame: 2nd year and 1st trimester of 3rd year]
Eligibility criteria
Inclusion criteria
- Patient aged 18 years old or more
- Newly diagnosed patient positive for HCV (presence of HCV antibodies)
- Patient with active infection (HCV RNA > 0)
Exclusion criteria
- Patients who decline to participate in the study and oppose the use of their personal data
- Patients under legal protection (guardianship or curatorship)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- AP-HP Henri Mondor — Créteil
Identifiers
NCT: NCT07503288 · APHP251362