Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille

• Conditions: Hepatitis C

• Registration Number: NCT05103085
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .

French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.

Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.

With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.

Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Study Start: 2022-01-24
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Aged ≥ 50
• Giving free and informed written consent
• Being affiliated with or benefiting from a social security scheme

Exclusion Criteria

• Patient unable to express consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.	16 months

Secondary Outcome Measures

Name	Time	Method
Number of patients who refuse viral screening	16 months
Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C	16 months
Number of viremic patients without risk factor	16 months

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France