Clinical trial NCT05936073: DELTA DESCRIBE: the French Collaborative Project
Official title: DELTA DESCRIBE: the French Collaborative Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D
Keywords: HBs Ag
Delta hepatitis
Screening
Reflex testing
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (\>18 years) chronically infected by HBV and HDV (RNA HDV positive) at the second step

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.

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

Primary outcomes:
measure: Number of anti-HDV and HDV RNA tests performed from 2016 to 2020 in metropolitan France
timeFrame: 12 months
measure: Number of anti-HDV and HDV RNA tests expected
timeFrame: 12 months
Secondary outcomes:
measure: Number of anti-HCV, anti-HIV and HBs Ag tests performed in metropolitan France from 2016 to 2020
timeFrame: 12 months
measure: Age, sex, residence department and profile of prescribers of patients receiving HDV, HBV, HIV and HCV tests
timeFrame: 12 months
measure: Number of anti-HDV and HDV RNA tests performed in 2019 by the laboratories in metropolitan France
timeFrame: 12 months
measure: Age, sex, profile of the prescribers of HDV RNA positive patients identified by the laboratories in 2019
timeFrame: 12 months
measure: Rate of use of the different HDV PCR techniques by the laboratories in 2019
timeFrame: 12 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Chu Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Véronique Loustaud-Ratti, Pr
role: PRINCIPAL_INVESTIGATOR
References: