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临床试验/NCT03642977
NCT03642977已完成不适用

DNA and RNA Viruses of the Blood Virome of Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Longitudinal Observational Study During a One-year Period After Transplantation - the Geneva Blood Virome Project (GeBVir)

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Plasmatic viral load kinetics of DNA and RNA viruses

研究概览

简要总结

The Geneva Blood Virome Project is a longitudinal observational study. The main objective is to describe the kinetics of the plasmatic viral load of a selection of at least 21 DNA and RNA viruses of the blood virome in allogeneic hematopoietic stem cell transplant recipients, over a one-year period after transplantation. Secondary objectives are: 1) to assess the prevalence of DNA and RNA viruses plasmatic detections and co-detections, 2) to assess the cumulative incidence of DNA and RNA viruses plasmatic detection. The population of the study consists in adult patients receiving allogeneic stem cell transplantation at the University Hospitals of Geneva, enrolled in an already existing monocentric cohort, and for which clinical specimens are collected and stored at the time and after transplantation. The investigators plan to include 120 patients whose plasma samples are collected from March 2017 and to systematically use plasma samples collected on the day of transplantation and several time points after transplantation to screen DNA and RNA viruses by qualitative and quantitative real-time PCR and RT-PCR.

详细描述

The Geneva Blood Virome Project is a longitudinal observational study. The main objective is to describe the kinetics of the plasmatic viral load of a selection of at least 21 DNA and RNA viruses of the blood virome (Herpesviridae Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae) in allogeneic hematopoietic stem cell transplant recipients, over a period of one year after transplantation. These DNA and RNA viruses can be responsible of acute infections, chronic infections or reactivations after transplantation. Secondary objectives are : 1) to assess the prevalence of DNA and RNA viruses plasmatic detections and co-detections at pre-specified time-points, 2) to assess the cumulative incidence of DNA and RNA viruses plasmatic detection at pre-specified time-points. The population of the study consists in adult patients receiving allogeneic stem cell transplantation at the University Hospitals of Geneva and who are enrolled in an already existing monocentric cohort named "Cohort of infectious disease in hematopoietic stem cell transplant patients" and for which clinical specimens are collected and stored at the time and after transplantation. The investigators plan to include 120 patients whose plasma samples are collected from March 2017 and to systematically use plasma samples collected at 5 pre-specified time points (the day of transplantation, 30 days, 3 months, 6 months, and one year after transplantation) to perform qualitative and quantitative real-time r(RT)-PCR assays for the screening of DNA and RNA viruses. The definitive analysis of results should be done by the end of 2020.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients receiving allogeneic stem cell transplantation since March 2017 at University Hospitals of Geneva
  • Enrollment in the "Cohort of infectious disease in hematopoietic stem cell transplant patients"
  • Signature of an informed consent form before transplantation

排除标准

  • Absence of a signed informed consent form for the "Cohort of infectious disease in hematopoietic stem cell transplant patients".

结局指标

主要结局

Plasmatic viral load kinetics of DNA and RNA viruses

时间窗: one-year period after transplantation

Measurement of the plasmatic viral load of DNA and RNA viruses belonging to the Herpesviridae, Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae families, with real time (RT-)PCR on plasma samples collected at pre-specified timepoints (the day of transplantation (D0), 30 days (D30), 3 months (M3), 6 months (M6) and one year (Y1) after transplantation) (expressed as fold-increase).

次要结局

  • Prevalence of plasmatic detection of DNA and RNA viruses(one-year period after transplantation)
  • Cumulative incidence of DNA and RNA viruses plasmatic detection(one-year period after transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie-Céline Zanella

Principal investigator

University Hospital, Geneva

研究点 (1)

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