Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients (HOSPI-VHC)
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|ClinicalTrials.gov Identifier: NCT04405024|
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : August 4, 2020
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.
The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Diagnostic Test: Hepatitis C testing||Not Applicable|
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.
It is in this context that "hepatitis free hospital" projects have been carried out in several French cities such as Nice, Nancy and Marseille.
The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening|
|Actual Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||November 2020|
Hepatitis C testing
If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment.
These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator.
Diagnostic Test: Hepatitis C testing
Hepatitis C Screening
- potential patient versus [ Time Frame: 7 days ]Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
- HCV positive [ Time Frame: 7 days ]Percentage positive for HCV
- Follow-up [ Time Frame: 2 months ]Percentage of patients referred for consultation if HCV positive
- Polymerase chain reaction (PCR) [ Time Frame: 7 days ]Percentage of HCV PCR positive patients
- Viral risk factor [ Time Frame: 7 days ]Percentage of patients with a viral risk factor
- hepatic fibrosis [ Time Frame: 7 days ]Percentage of patients with hepatic fibrosis
- treatment initiation [ Time Frame: 2 months ]Percentage of patients benefiting from treatment initiation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405024
|Contact: Isabelle Rosa, PhD||01 45 17 50 00 ext +email@example.com|
|Contact: Camille JUNG||01 45 17 50 00 ext +firstname.lastname@example.org|
|Créteil, France, 94000|
|Contact: Isabelle Rosa email@example.com|
|Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée||Recruiting|
|Contact: Gilles MACAIGNE firstname.lastname@example.org|
|Contact: Hatem SALLOUM email@example.com|
|Contact: Armand GARIOUD Armand.Garioud@chiv.fr|