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临床试验/NCT04405024
NCT04405024终止不适用

Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening

Centre Hospitalier Intercommunal Creteil5 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2020年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
117
试验地点
5
主要终点
potential patient versus

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years of age
  • Hospitalized during the study period
  • Non-opposition for participation in the Protocol

排除标准

  • Patients under 18 years of age
  • Outpatient, long-stay, maternity and intensive care inpatients
  • Patients refusing blood collection
  • Patient may not understand the information sheet
  • Patient under guardianship

研究组 & 干预措施

Hepatitis C testing

Other

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.

干预措施: Hepatitis C testing (Diagnostic Test)

结局指标

主要结局

potential patient versus

时间窗: 7 days

Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.

次要结局

  • HCV positive(7 days)
  • Follow-up(2 months)
  • Polymerase chain reaction (PCR)(7 days)
  • Viral risk factor(7 days)
  • treatment initiation(2 months)
  • hepatic fibrosis(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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