Hepatitis C Screening Paired With Mammography

NCT ID: NCT05067374

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2025-03-23

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène DONNADIEU RIGOLE, Pr

Role: PRINCIPAL_INVESTIGATOR

Biochemistry department

Locations

Beausoleil private clinic

Montpellier, Occitanie, France

Site Status: NOT_YET_RECRUITING

Lapeyronie radiology ward (Montpellier University hospital)

Montpellier, Occitanie, France

Site Status: RECRUITING

Le Millénaire private clinic

Montpellier, Occitanie, France

Site Status: RECRUITING

Victor Hugo Center

Montpellier, Occitanie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Helene DONNADIEU RIGOLE, MH PD

Role: CONTACT

h-donnadieu_rigole@chu-montpellier.fr

04 67 33 70 20

Facility Contacts

Muriel Trentini, MD

Role: primary

04 67 75 97 59

Patrice Taourel, Pr

Role: primary

p-taourel@chu-montpellier.fr

04 67 33 86 10

Emma Pages Bouic, MD

Role: backup

e-pages@chu-montpellier.fr

Nathalie Fabre-Demard, MD

Role: primary

04 99 53 60 60

Nathalie Fabre-Demard, MD

Role: primary

senovictorhugo@gmail.com

04 67 12 87 88

Other Identifiers

RECHMPL20_0005-UF7919

Identifier Type: -

Identifier Source: org_study_id