NCT05103085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 10, 2022

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

October 21, 2021

Last Update Submit

February 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.

    16 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

Experimental

Patient undergoing digestive endoscopy and aged 50 years and over

Diagnostic Test: Rapid diagnostic orientation test (TROD) for Hepatitis C

Interventions

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.

Experimental

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 50 and over hospitalized in the digestive endoscopy department

You may qualify if:

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

You may not qualify if:

  • \- Patient unable to express consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Européen Marseille

Marseille, 13003, France

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

January 24, 2022

Primary Completion

March 1, 2023

Study Completion

September 1, 2023

Last Updated

February 10, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations