Hepatitis CMammo'CNCT05067374
Hepatitis C Screening Paired With Mammography
An observational study of Hepatitis C and Breast Cancer, run by University Hospital, Montpellier at 4 sites in France.
Trial summary
In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Breast Cancer
- How many people
- 1,500 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Mar 2022to 14 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women participating in the organized systematic breast cancer screening
Who may be able to join
- - Women aged 50-74 inclusive
- Doing a breast cancer screening
- Able to understand and complete a questionnaire on their own or with the help of a third party
- Able to understand the study and follow the protocol
- Having signed the consent form
- With social security plan
Who cannot join
- - Cannot sign the consent or follow the protocol
- Under French legal protection measure (sauvegarde de justice, tutelle or curatelle)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Beausoleil private clinic
Montpellier, Occitanie, 34000
Lapeyronie radiology ward (Montpellier University hospital)
Montpellier, Occitanie, 34000
Le Millénaire private clinic
Montpellier, Occitanie, 34000
Victor Hugo Center
Montpellier, Occitanie, 34000
About this study
Official title: Screening for the Hepatitis C Virus by TROD Paired With Mammography and Management of Chronic Hepatitis C in Women Aged 50 to 74 in the Agglomeration of Montpellier
In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. To answer the WHO objective of eliminating hepatitis C by 2030 and in France by 2025, the investigators need to organize targeted screening. Women aged more than 50 years old, by their possible antecedents in life, are an exposed population. The investigators propose to pair the already organized breast cancer screening with a hepatitis-screening test by rapid diagnostic orientation test (TROD) and evaluate the adherence of women in this paired screening. For women with positive TROD, a specialized care will be organized.
Read the detailed description
Context :
Organized breast cancer screening has been introduced in France since 2004. It concerns women aged 50 to 74 years old with average risk (no symptoms and no risk factors). This systematic screening reaches approximately 70% of the includable women. At the same time, it is estimated that 10 to 15% of women aged 50 to 74 undergo screening as part of an individual detection process.
The seroprevalence of hepatitis C in the general French population is less than 1%, but it is estimated that around 75,000 people living with the virus are unaware of their seropositivity. Among them, the risk of a late diagnosis is the risk of cirrhosis or hepatocellular carcinoma. Screening for hepatitis C is also justified now that the new treatments is universally accessible with a remarkable efficacy (>95%). These pan-genotypic treatments are of short duration and have very few adverse effects.
The WHO has set a goal of eliminating hepatitis by 2030 and France has gone a step further and proposed an elimination date of 2025. These objectives are not achievable without improved screening, the cornerstone of access to treatment. The objective is therefore to propose targeted screening in certain sub-population to organize micro elimination phenomena. Women over 50 years of age constitute a sub population at risk.
Objectives :
The objective of the study is to evaluate the adherence rate of women aged 50 to 74 years to hepatitis C screening by TROD paired with systematic breast cancer screening.
The secondary objectives of the study are, among women aged 50-74 presenting for breast cancer screening in the city of Montpellier, to estimate:
- The prevalence of viral hepatitis C
- The prevalence of chronic viral hepatitis C
- The retrospective care cascade of hepatitis C in women screened positive for chronic hepatitis C
- Access to hepatitis C care among positive for chronic hepatitis C
Methodology:
Type of study: Prospective screening procedure evaluation study.
Primary endpoint:
- The number of women who agreed to undergo the HCV test among those who were offered the test will be calculated = adherence to the proposed screening.
Secondary endpoints:
- Number of hepatitis C positive TRODs compared to the number of TRODs performed
- Number of HCV RNA positives among the number of hepatitis C positive TRODs.
- Retrospective chronic viral hepatitis C care cascade for participants with a positive TROD
- Access to care and prospective cascade of care
Statistical analysis:
The main analyses will be descriptive. The main characteristics of the participants will be described by the mean/standard deviation or median/interquartile range when the variable is quantitative and by a proportion with confidence interval when the variable is qualitative.
The judgment criteria will be described by percentages with their 95% confidence intervals. The fibrosis score will be presented in classes.
- Conditions
- Hepatitis C, Breast Cancer
- Keywords
- Rapid orientation diagnostic test, Hepatitis C, Breast cancer, Mammography, Blood sample, Paired screening
- Medical subject headings
- Hepatitis C, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the hepatitis C screening
Description: Number of women who have agreed to do the hepatitis C screening by rapid orientation diagnostic test (TROD) among the woman to whom it was offered.
Measured: At inclusion
Secondary outcomes (12)
Percentage of positive hepatitis C TROD
Number of positive TROD among the number of TROD done
Measured: At inclusion
Percentage of positive hepatitis C RNA
Number of positive HCV RNA blood samples among the positive TROD for hepatitis C
Measured: at 1 year after inclusion day
Retrospective care cascade : percentage of women with knowledge of their positive serological status
Number of women with knowledge of their HCV serological status among women with a TROD
Measured: At inclusion day
Retrospective care cascade : percentage of women with a HCV viral load done
Number of women with a HCV viral load done in the past among the women with knowledge of their positive serological status.
Measured: At inclusion day
Retrospective care cascade : percentage of treated women
Number of women who had already been treated for hepatitis C in the past among women with a positive viral HCV charge.
Measured: At inclusion day
Retrospective care cascade : percentage of women cured
Number of women who had already been cured of HCV in the past among the women treated.
Measured: at 1 year after inclusion day
Care access and prospective care cascade : percentage of women with a blood test done
Number of women with a blood test done among the number of prescriptions given when the TROD is positive
Measured: At inclusion day
Care access and prospective care cascade : percentage of women with positive HCV RNA
Number of women with a positive HCV RNA blood test among women with a prescribed blood test
Measured: at 1 year after inclusion day
Care access and prospective care cascade : percentage of women who consulted with the hepatologist
Number of women who had a consultation with the hepatologist among women with a positive TROD
Measured: At inclusion day
Care access and prospective care cascade : percentage of women who initiated the treatment
Number of women who initiated their treatment among women with a positive HCV RNA in women who had a consultation with the hepatologist
Measured: At inclusion day
Care access and prospective care cascade : Fibrosis score
Fibrosis score of women who had the prescribed blood test done
Measured: At inclusion day
Care access and prospective care cascade : percentage of cured women
Number of women cured for HCV 12 weeks after the end of treatment among women who initiated the treatment
Measured: 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start23 Mar 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Hélène DONNADIEU RIGOLE, Pr, Principal investigator, Biochemistry department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067374
- Sponsor's protocol ID
- RECHMPL20_0005-UF7919
- Acronym
- Mammo'C
- Status last verified
- May 2026
- First submitted
- 23 Sep 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meszaros M, Coursier S, Nagot N, Moulis L, Taourel P, Pages-Bouic E, Fabre-Demard N, Trentini M, Pageaux GP, Donnadieu H. Screening for hepatitis C virus at the time of mammography using rapid diagnostic tests in women aged between 50 and 74 years (Mamm'OC NCT05067374). J Viral Hepat. 2024 Jul;31(7):416-422. doi: 10.1111/jvh.13947. Epub 2024 May 15.
PubMed 38749911
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for the Hepatitis C Virus by TROD Paired With Mammography and Management of Chronic Hepatitis C in Women Aged 50 to 74 in the Agglomeration of Montpellier
- ClinicalTrials.gov ID
- NCT05067374
- Acronym / sponsor ID
- Mammo'C / RECHMPL20_0005-UF7919
- Conditions
- Hepatitis C, Breast Cancer
- Keywords
- Rapid orientation diagnostic test, Hepatitis C, Breast cancer, Mammography, Blood sample, Paired screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 5 Oct 2021 (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.
In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. To answer the WHO objective of eliminating hepatitis C by 2030 and in France by 2025, the investigators need to organize targeted screening. Women aged more than 50 years old, by their possible antecedents in life, are an exposed population. The investigators propose to pair the already organized breast cancer screening with a hepatitis-screening test by rapid diagnostic orientation test (TROD) and evaluate the adherence of women in this paired screening. For women with positive TROD, a specialized care will be organized.
Detailed description
Context :
Organized breast cancer screening has been introduced in France since 2004. It concerns women aged 50 to 74 years old with average risk (no symptoms and no risk factors). This systematic screening reaches approximately 70% of the includable women. At the same time, it is estimated that 10 to 15% of women aged 50 to 74 undergo screening as part of an individual detection process.
The seroprevalence of hepatitis C in the general French population is less than 1%, but it is estimated that around 75,000 people living with the virus are unaware of their seropositivity. Among them, the risk of a late diagnosis is the risk of cirrhosis or hepatocellular carcinoma. Screening for hepatitis C is also justified now that the new treatments is universally accessible with a remarkable efficacy (>95%). These pan-genotypic treatments are of short duration and have very few adverse effects.
The WHO has set a goal of eliminating hepatitis by 2030 and France has gone a step further and proposed an elimination date of 2025. These objectives are not achievable without improved screening, the cornerstone of access to treatment. The objective is therefore to propose targeted screening in certain sub-population to organize micro elimination phenomena. Women over 50 years of age constitute a sub population at risk.
Objectives :
The objective of the study is to evaluate the adherence rate of women aged 50 to 74 years to hepatitis C screening by TROD paired with systematic breast cancer screening.
The secondary objectives of the study are, among women aged 50-74 presenting for breast cancer screening in the city of Montpellier, to estimate:
- The prevalence of viral hepatitis C
- The prevalence of chronic viral hepatitis C
- The retrospective care cascade of hepatitis C in women screened positive for chronic hepatitis C
- Access to hepatitis C care among positive for chronic hepatitis C
Methodology:
Type of study: Prospective screening procedure evaluation study.
Primary endpoint:
- The number of women who agreed to undergo the HCV test among those who were offered the test will be calculated = adherence to the proposed screening.
Secondary endpoints:
- Number of hepatitis C positive TRODs compared to the number of TRODs performed
- Number of HCV RNA positives among the number of hepatitis C positive TRODs.
- Retrospective chronic viral hepatitis C care cascade for participants with a positive TROD
- Access to care and prospective cascade of care
Statistical analysis:
The main analyses will be descriptive. The main characteristics of the participants will be described by the mean/standard deviation or median/interquartile range when the variable is quantitative and by a proportion with confidence interval when the variable is qualitative.
The judgment criteria will be described by percentages with their 95% confidence intervals. The fibrosis score will be presented in classes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women participating in the organized systematic breast cancer screening
Key inclusion criteria (6 listed)
- - Women aged 50-74 inclusive
- Doing a breast cancer screening
- Able to understand and complete a questionnaire on their own or with the help of a third party
- Able to understand the study and follow the protocol
- Having signed the consent form
Key exclusion criteria (2 listed)
- - Cannot sign the consent or follow the protocol
- Under French legal protection measure (sauvegarde de justice, tutelle or curatelle)
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
Adherence to the hepatitis C screening
Time frame: At inclusion
Description: Number of women who have agreed to do the hepatitis C screening by rapid orientation diagnostic test (TROD) among the woman to whom it was offered.
12 secondary outcomes
Percentage of positive hepatitis C TROD
Time frame: At inclusion
Percentage of positive hepatitis C RNA
Time frame: at 1 year after inclusion day
Retrospective care cascade : percentage of women with knowledge of their positive serological status
Time frame: At inclusion day
Retrospective care cascade : percentage of women with a HCV viral load done
Time frame: At inclusion day
Retrospective care cascade : percentage of treated women
Time frame: At inclusion day
Retrospective care cascade : percentage of women cured
Time frame: at 1 year after inclusion day
Care access and prospective care cascade : percentage of women with a blood test done
Time frame: At inclusion day
Care access and prospective care cascade : percentage of women with positive HCV RNA
Time frame: at 1 year after inclusion day
Care access and prospective care cascade : percentage of women who consulted with the hepatologist
Time frame: At inclusion day
Care access and prospective care cascade : percentage of women who initiated the treatment
Time frame: At inclusion day
Care access and prospective care cascade : Fibrosis score
Time frame: At inclusion day
Care access and prospective care cascade : percentage of cured women
Time frame: 12 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 38749911Meszaros M, Coursier S, Nagot N, Moulis L, Taourel P, Pages-Bouic E, Fabre-Demard N, Trentini M, Pageaux GP, Donnadieu H. Screening for hepatitis C virus at the time of mammography using rapid diagnostic tests in women aged between 50 and 74 years (Mamm'OC NCT05067374). J Viral Hepat. 2024 Jul;31(7):416-422. doi: 10.1111/jvh.13947. Epub 2024 May 15.
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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. This study is not recruiting at the moment.
Hélène DONNADIEU RIGOLE, Pr principal investigator
Biochemistry department
4 sites 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 and Breast Cancer, run by University Hospital, Montpellier at 4 sites 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 6 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: finished, as of the sponsor's last update on 14 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 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the hepatitis C screening (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067374, which also lists 1 linked publication.
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 14 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.