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 (TROCENDO)

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Diagnostic test: Rapid diagnostic orientation test (TROD) for Hepatitis C

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Myriam BENNANI; Phone Number: +33 0413428351; Email: m.bennani@hopital-europeen.fr

Study Locations

• France
  • Marseille, France, 13003
    • Recruiting
    • Hôpital Européen Marseille
    • Contact: Myriam BENNANI; Phone Number: +33 0413428351; Email: m.bennani@hopital-europeen.fr
    • Principal Investigator: Patrick DUKAN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50 and over hospitalized in the digestive endoscopy department

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Patient undergoing digestive endoscopy and aged 50 years and over	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 21-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No