NCT05936073

DELTA DESCRIBE: the French Collaborative Project

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 734 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-06-22
• Completion: 2025-06-22
• First posted: 2023-07-07
• Last updated: 2025-05-28

Locations

1 site across 1 country: France