Hepatitis C VirusCARTO-VHCNCT07503288
Genotype and Subtype Mapping of the Hepatitis C Virus
An observational study of Hepatitis C Virus and Mutation Abnormality, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus, Mutation Abnormality, RNA Positive
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Defined population
Who may be able to join
- Patient aged 18 years old or more
- Newly diagnosed patient positive for HCV (presence of HCV antibodies)
- Patient with active infection (HCV RNA > 0)
Who cannot join
- Patients who decline to participate in the study and oppose the use of their personal data
- Patients under legal protection (guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
AP-HP Henri Mondor
Créteil, 94000
Laetitia GREGOIRE, +33 1 49 81 41 64, laetitia.gregoire@aphp.fr
Sara MASMOUDI, +33 1 49 81 44 86, sara.masmoudi@aphp.fr
About this study
Official title: Cartographie Des génotypes et Sous-types du Virus de l'hépatite C
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:
- 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.
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.
Measured: 1st year
Secondary outcomes (6)
Proportion of patients with cirrhosis
Measured: last 6 month of 1st year
Proportion of patients infected with an "unusuel" subtype
Measured: 1st 6 month of 3rd year
Proportion of viruses carrying polymorphisms in the NS3, NS5A, and/or NS5B genes among the "unusuel" subtypes
Measured: Last 6 month of 2nd year and first 6 month of 3rd year
Proportion of patients with treatment failure
Measured: 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
Measured: Last 6 month of 3rd year
Proportion of patients born in Asia and Africa
Measured: 2nd year and 1st trimester of 3rd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane CHEVALIEZ, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503288
- Sponsor's protocol ID
- APHP251362
- Acronym
- CARTO-VHC
- Status last verified
- May 2026
- First submitted
- 25 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartographie Des génotypes et Sous-types du Virus de l'hépatite C
- ClinicalTrials.gov ID
- NCT07503288
- Acronym / sponsor ID
- CARTO-VHC / APHP251362
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Defined population
Key inclusion criteria (3 listed)
- Patient aged 18 years old or more
- Newly diagnosed patient positive for HCV (presence of HCV antibodies)
- Patient with active infection (HCV RNA > 0)
Key exclusion criteria (2 listed)
- Patients who decline to participate in the study and oppose the use of their personal data
- Patients under legal protection (guardianship or curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations.
Time frame: 1st year
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane CHEVALIEZ study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus and Mutation Abnormality, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane CHEVALIEZ (+33 1 49 81 28 28, stephane.chevaliez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of genotypes and subtypes stratified by age and sex in each of the studied populations. (time frame: 1st year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.