DELTA DESCRIBE: the French Collaborative Project

NCT ID: NCT05936073

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 734 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2025-06-22

Brief Summary

Our global objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, the first step for specialized care pathway in metropolitan France.

Detailed Description

Hepatitis Delta virus (HDV) infection is a significant public health disease causing up to 18% of cirrhosis and 20% of hepatocellular carcinoma (HCC) and new therapeutic options are now available. In France, very few epidemiological studies, mainly focused on specific pre-selected hospital populations, are available. There is a crucial need for data in terms of Delta knowledge, suitability of screening, type of prescribers and treatment access. The investigator proposes a retrospective study in order to describe the number of HDV tests (anti-HDV and HDV RNA) performed in metropolitan France and compare it to the potentially expected one, estimated from the number of HBV screening tests performed in one year, from 2016 to 2020. The investigator will also evaluate the number of HCV and HIV screening tests prescribed over the same period and the HDV PCR techniques used. This study will be based on one hand on data from the French Health insurance (first step) and on the other hand on data from private and hospital laboratories (second step). The second step will allow to identify the prescriber of the Delta tests and the HDV positive patients and precise their profile and their medical care. After an initial analysis of the results, The investigator will propose solutions to the barriers encountered and adapted to the identified targets.

Conditions

Hepatitis D

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Patients co-infected HBV/HDV

Step 1: collection of SNDS data from 2016 to 2020 Snapshot of the prescription of the Delta tests and the tests usually prescribed simultaneously (HBV but also HIV and HCV) in one year. The investigator will collect the number of tests performed once for a given patient: anti-HDV, HDV RNA, HBsAg, anti-HCV, anti-HIV, and for each test, the description of the profile and the geographical distribution of prescribers in the metropolitan area; the description of age and sex of the patients screened. Step 2: collection of anti-HDV and RNA tests performed in French private and Public laboratories over the year 2019 Anti-HDV and HDV RNA are subcontracted by most private laboratories to two specialized biology companies. Number of HDV tests prescribed, technique used, number of positive tests and name of the requesting laboratory will be collected. The investigator will then go back to the prescriber of the positive tests, identify the patient, his epidemiological profile and his medical care.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• >18 years at the second step
• HDV RNA positive patients identified at the second step
• Patients non opposed to the collection of their data

Exclusion Criteria

• Opposition expressed by the patients for the collection of their data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique Loustaud-Ratti, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

Chu Limoges

Limoges, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sandra Juge

Role: CONTACT

Sandra.Juge@chu-limoges.fr

0555056414 ext. 33

Céline Rigaud

Role: CONTACT

celine.rigaud@chu-limoges.fr

Facility Contacts

Sandra Juge

Role: primary

Sandra.Juge@chu-limoges.fr

0555056414 ext. 33

Other Identifiers

87RI21_0068

Identifier Type: -

Identifier Source: org_study_id