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临床试验/NCT05622032
NCT05622032已完成不适用

Blood Virome After Haploidentical Hematopoietic Stem Cell Transplantation, a Pilot Study

Laurent Kaiser1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Describe the blood virome in haploidentical and HLA-matched allo-HSCT recipients during the first 6 months after transplantation.

研究概览

简要总结

The goal of this observational study is to assess the risk of viral infections in patients receiving hematopoietic stem cell transplantation (HSCT) from a haploidentical donor compared to those who receive HSCT from a HLA-matched donor. The main question it aims to answer is: to describe which viruses are replicating in the blood of the above two patient groups on the day of transplantation and at 1, 3 and 6 months after transplantation. Blood samples taken as part of routine care on the day of transplantation and at 1, 3 and 6 months post-transplantation visits are analyzed and the types and amount of viruses detected in the two groups of patients are described.

详细描述

Geneva University Hospitals are one of the three centers performing allogeneic HSCT in Switzerland. Since several years the Division of infectious diseases runs a collaborative research program with the Division of Hematology. In 2015 the two divisions jointly created a prospective cohort of allo-HSCT patients called: "Infectious diseases in hematopoietic stem cell transplant patients cohort" enrolling potentially all adult patients engrafted in our center since 2015 (CCER protocol 15-120 and relative amendments). The cohort compiles clinical data on hematological and infectious complications occurring up to one year after transplantation and biological specimen collected systematically until up to 2 years after transplantation, which are stored in a joint biobank.

研究设计

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

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 at the Geneva University Hospitals from a haploidentical or from an HLA-matched donor, who signed the informed consent form before transplantation for inclusion in the prospective cohort of "Infectious disease in hematopoietic stem cell transplant patients".

排除标准

  • 未提供

结局指标

主要结局

Describe the blood virome in haploidentical and HLA-matched allo-HSCT recipients during the first 6 months after transplantation.

时间窗: 6 months after transplantation

Describe the types of viruses detected as well as their frequency in the blood virome of haplo- HSCT patients compared to the HLA-matched group by metagenomic next generation sequencing

次要结局

未报告次要终点

研究者

发起方
Laurent Kaiser
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laurent Kaiser

Head, Division of Infectious Diseases

University Hospital, Geneva

研究点 (1)

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