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NCT Number: NCT07503288

Genotype and Subtype Mapping of the Hepatitis C Virus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The study will consist of the following:

  • Inclusion of patients who meet the selection criteria (hospitalized patients and outpatients from tertiary centers in mainland France) ;
  • Collecting all associated data, including demographic, clinical, and therapeutic information. A Clinical research technician may be assigned to centers lacking sufficient human resources;
  • 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;
  • Perform molecular biology genotyping techniques (RNA extraction, PCR, and Sanger sequencing of a portion of the NS5B gene);
  • Carry out next-generation sequencing (Seq2000, Illumina) of the full genome of "unusual" subtype strains, or DAAs resistant patients
  • Analyze genotype and subtype information, as well as its correlation with demographic, clinical, and therapeutic data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.

    Time frame: 1st year

Secondary outcomes

  1. Proportion of patients with cirrhosis

    Time frame: last 6 month of 1st year

  2. Proportion of patients infected with an "unusuel" subtype

    Time frame: 1st 6 month of 3rd year

  3. 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

  4. Proportion of patients with treatment failure

    Time frame: Trim 2 and trim 3 of 3rd year

  5. 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

  6. Proportion of patients born in Asia and Africa

    Time frame: 2nd year and 1st trimester of 3rd year

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane CHEVALIEZ

CONTACT

[email protected]

+33 1 49 81 28 28

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cartographie Des génotypes et Sous-types du Virus de l'hépatite C

Acronym: CARTO-VHC

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 31, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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