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Not yet recruitingNCT07503288CARTO-VHCUpdated May 19, 2026

Genotype and Subtype Mapping of the Hepatitis C Virus

An observational study in Hepatitis C Virus, Mutation Abnormality and RNA Positive, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Hepatitis C Virus
  • Mutation Abnormality
  • RNA Positive
  • Unusual Subtype
  • Resistance

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Defined population

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

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)
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,500 participants (estimated)
Patient registry
No
05

What researchers measure

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

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07503288
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 31, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
May 19, 2026

Study contacts

Stéphane CHEVALIEZ
Contact
stephane.chevaliez@aphp.fr
+33 1 49 81 28 28
Stéphane CHEVALIEZ
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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