Hepatitis C Screening Paired With Mammography

Breast Cancer Clinical Trial

— Mammo'C  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067374
• Other study ID #: RECHMPL20_0005-UF7919
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: March 23, 2025

Study information

• Verified date: March 2022
• Source: University Hospital, Montpellier
• Contact: Helene DONNADIEU RIGOLE, MH PD
• Phone: 04 67 33 70 20
• Email: h-donnadieu_rigole[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 23, 2025
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• - 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

Exclusion Criteria:

• - Cannot sign the consent or follow the protocol

• Under French legal protection measure (sauvegarde de justice, tutelle or curatelle)

Related Conditions & MeSH terms

• Breast Cancer
• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
France	Beausoleil private clinic	Montpellier	Occitanie
France	Lapeyronie radiology ward (Montpellier University hospital)	Montpellier	Occitanie
France	Le Millénaire private clinic	Montpellier	Occitanie
France	Victor Hugo Center	Montpellier	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At inclusion
Secondary	Percentage of positive hepatitis C TROD	Number of positive TROD among the number of TROD done	At inclusion
Secondary	Percentage of positive hepatitis C RNA	Number of positive HCV RNA blood samples among the positive TROD for hepatitis C	at 1 year after inclusion day
Secondary	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	At inclusion day
Secondary	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.	At inclusion day
Secondary	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.	At inclusion day
Secondary	Retrospective care cascade : percentage of women cured	Number of women who had already been cured of HCV in the past among the women treated.	at 1 year after inclusion day
Secondary	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	At inclusion day
Secondary	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	at 1 year after inclusion day
Secondary	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	At inclusion day
Secondary	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	At inclusion day
Secondary	Care access and prospective care cascade : Fibrosis score	Fibrosis score of women who had the prescribed blood test done	At inclusion day
Secondary	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	12 weeks after the end of treatment