DELTA DESCRIBE: the French Collaborative Project
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Patients co-infected HBV/HDV.
- Кому может быть актуально
- Состояния в реестре: Hepatitis D. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест 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.
Первичные конечные точки
- Number of anti-HDV and HDV RNA tests performed from 2016 to 2020 in metropolitan France [Срок оценки: 12 months]
- Number of anti-HDV and HDV RNA tests expected [Срок оценки: 12 months]
Вторичные конечные точки (5)
- Number of anti-HCV, anti-HIV and HBs Ag tests performed in metropolitan France from 2016 to 2020 [Срок оценки: 12 months]
- Age, sex, residence department and profile of prescribers of patients receiving HDV, HBV, HIV and HCV tests [Срок оценки: 12 months]
- Number of anti-HDV and HDV RNA tests performed in 2019 by the laboratories in metropolitan France [Срок оценки: 12 months]
- Age, sex, profile of the prescribers of HDV RNA positive patients identified by the laboratories in 2019 [Срок оценки: 12 months]
- Rate of use of the different HDV PCR techniques by the laboratories in 2019 [Срок оценки: 12 months]
Критерии участия
Критерии включения
- >18 years at the second step
- HDV RNA positive patients identified at the second step
- Patients non opposed to the collection of their data
Критерии исключения
- Opposition expressed by the patients for the collection of their data
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Chu Limoges — Limoges
Идентификаторы
NCT: NCT05936073 · 87RI21_0068