Association of Hepatitis C Virus With Breast Cancer
NCT04090164
Blood-Borne Infections, Breast Cancer
Al Mansurah, DK, Egypt
View Trial DetailsNCT Number: NCT05067374
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.
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Notify Me50 year–74 year
Female
Observational
Beausoleil private clinic, Montpellier, Occitanie, France
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:
Methodology:
Type of study: Prospective screening procedure evaluation study.
Primary endpoint:
Secondary endpoints:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At inclusion
Number of positive TROD among the number of TROD done
Time frame: at 1 year after inclusion day
Number of positive HCV RNA blood samples among the positive TROD for hepatitis C
Time frame: At inclusion day
Number of women with knowledge of their HCV serological status among women with a TROD
Time frame: At inclusion day
Number of women with a HCV viral load done in the past among the women with knowledge of their positive serological status.
Time frame: At inclusion day
Number of women who had already been treated for hepatitis C in the past among women with a positive viral HCV charge.
Time frame: at 1 year after inclusion day
Number of women who had already been cured of HCV in the past among the women treated.
Time frame: At inclusion day
Number of women with a blood test done among the number of prescriptions given when the TROD is positive
Time frame: at 1 year after inclusion day
Number of women with a positive HCV RNA blood test among women with a prescribed blood test
Time frame: At inclusion day
Number of women who had a consultation with the hepatologist among women with a positive TROD
Time frame: At inclusion day
Number of women who initiated their treatment among women with a positive HCV RNA in women who had a consultation with the hepatologist
Time frame: At inclusion day
Fibrosis score of women who had the prescribed blood test done
Time frame: 12 weeks after the end of treatment
Number of women cured for HCV 12 weeks after the end of treatment among women who initiated the treatment
University Hospital, Montpellier
Other
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
Acronym: Mammo'C
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