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

Hepatitis C Clinical Trial

— TROCENDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103085
• Other study ID #: 21-24
• Status: Recruiting
• Start date: January 24, 2022
• Est. completion date: September 2023

Study information

• Verified date: October 2021
• Source: Hôpital Européen Marseille
• Contact: Myriam BENNANI
• Phone: 0413428351
• Email: m.bennani[@]hopital-europeen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Diagnostic Test:
• Rapid diagnostic orientation test (TROD) for Hepatitis C
Inclusion of patients during the consultation with the gastroenterologist, before hospitalization in the digestive endoscopy department. Each consenting patient benefits from a HCV screening using TROD on the day of their hospitalization in the department.

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.		16 months
Secondary	Number of patients who refuse viral screening		16 months
Secondary	Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C		16 months
Secondary	Number of viremic patients without risk factor		16 months