Clinical trial NCT05067374: Hepatitis C Screening Paired With Mammography
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Breast Cancer
Keywords: Rapid orientation diagnostic test
Hepatitis C
Breast cancer
Mammography
Blood sample
Paired screening
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-10-05
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women participating in the organized systematic breast cancer screening

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.

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)

Primary outcomes:
measure: Adherence to the hepatitis C screening
timeFrame: At inclusion
Secondary outcomes:
measure: Percentage of positive hepatitis C TROD
timeFrame: At inclusion
measure: Percentage of positive hepatitis C RNA
timeFrame: at 1 year after inclusion day
measure: Retrospective care cascade : percentage of women with knowledge of their positive serological status
timeFrame: At inclusion day
measure: Retrospective care cascade : percentage of women with a HCV viral load done
timeFrame: At inclusion day
measure: Retrospective care cascade : percentage of treated women
timeFrame: At inclusion day
measure: Retrospective care cascade : percentage of women cured
timeFrame: at 1 year after inclusion day
measure: Care access and prospective care cascade : percentage of women with a blood test done
timeFrame: At inclusion day
measure: Care access and prospective care cascade : percentage of women with positive HCV RNA
timeFrame: at 1 year after inclusion day
measure: Care access and prospective care cascade : percentage of women who consulted with the hepatologist
timeFrame: At inclusion day
measure: Care access and prospective care cascade : percentage of women who initiated the treatment
timeFrame: At inclusion day
measure: Care access and prospective care cascade : Fibrosis score
timeFrame: At inclusion day
measure: Care access and prospective care cascade : percentage of cured women
timeFrame: 12 weeks after the end of treatment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Beausoleil private clinic
state: Occitanie
city: Montpellier
country: France
facility: Lapeyronie radiology ward (Montpellier University hospital)
state: Occitanie
city: Montpellier
country: France
facility: Le Millénaire private clinic
state: Occitanie
city: Montpellier
country: France
facility: Victor Hugo Center
state: Occitanie
Study officials:
affiliation: Biochemistry department
name: Hélène DONNADIEU RIGOLE, Pr
role: PRINCIPAL_INVESTIGATOR
References: