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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 8
- 主要终点
- Adherence to the hepatitis C screening
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- 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
排除标准
- •- Cannot sign the consent or follow the protocol
- •Under French legal protection measure (sauvegarde de justice, tutelle or curatelle)
结局指标
主要结局
Adherence to the hepatitis C screening
时间窗: 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.
次要结局
- Percentage of positive hepatitis C TROD(At inclusion)
- Percentage of positive hepatitis C RNA(at 1 year after inclusion day)
- Retrospective care cascade : percentage of women with knowledge of their positive serological status(At inclusion day)
- Retrospective care cascade : percentage of women with a HCV viral load done(At inclusion day)
- Retrospective care cascade : percentage of treated women(At inclusion day)
- Retrospective care cascade : percentage of women cured(at 1 year after inclusion day)
- Care access and prospective care cascade : percentage of women with a blood test done(At inclusion day)
- Care access and prospective care cascade : percentage of women with positive HCV RNA(at 1 year after inclusion day)
- Care access and prospective care cascade : percentage of women who consulted with the hepatologist(At inclusion day)
- Care access and prospective care cascade : percentage of women who initiated the treatment(At inclusion day)
- Care access and prospective care cascade : Fibrosis score(At inclusion day)
- Care access and prospective care cascade : percentage of cured women(12 weeks after the end of treatment)