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临床试验/NCT04412811
NCT04412811已完成不适用

A Prospective, Multicenter Survey of Cytomegalovirus (CMV) and Other Herpesviruses Infections and Diseases in Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Recipients.

Gruppo Italiano Trapianto di Midollo Osseo50 个研究点 分布在 1 个国家目标入组 1,310 人开始时间: 2021年1月1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
1,310
试验地点
50
主要终点
Cytomegalovirus infection

研究概览

简要总结

Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment) from GITMO investigational centers.

详细描述

This is a prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, italian on patients submitted to allogeneic haematopoietic stem cell transplantation organized under the auspices of the Gruppo Italiano Trapianti di Midollo Osseo that involves the principal Centres active in transplantation of any kind of hematopoietic stem cells in Italy.

Allogeneic haematopoietic stem cell transplantation patients continue to be one of the highest risk categories for developing viral infections. Cytomegalovirus infection is the leading viral cause of morbidity and mortality and HHV6 and EBV are other major causes of complications in transplant. The risk of these infections is directly related to the type of transplant.

A better and continuous monitoring of Cytomegalovirus and other herpesviruses complication in this setting would contribute to a better knowledge of the evolving epidemiology and would lead to a better use of diagnostic strategies and of preventive and therapeutic measures.

This study is aimed to identify epidemiological characteristics of allogeneic haematopoietic stem cell transplantation patients developing cytomegalovirus and other herpesviruses infections, risk factors, diagnostic peculiarities and factors that may guide to pre-emptive therapy versus prophylaxis strategies.

Virological monitoring and health care resources utilization in Allogeneic haematopoietic stem cell transplantation recipients according to the different risk of viral infection will be also assessed. This prospective analysis will provide useful information for local clinicians to define tailored antiviral strategies in line with the change of transplantation procedures.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Prospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian with objective to describe the incidence of CMV infections and diseases in adult and pediatric patients undergoing allo-HSCT during the first 6 months from transplant. This study will evaluate approximately 1500 subjects, with competitive enrolment from GITMO investigational centers.

排除标准

  • Absence of consent Written information

结局指标

主要结局

Cytomegalovirus infection

时间窗: 6 months from transplant

incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation

Cytomegalovirus disease

时间窗: 6 months from transplant

incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation

Herpesvirus human 6 disease

时间窗: 6 months from transplant

incidence of human 6 disease after allogeneic haematopoietic stem cell transplantation

Virus Epstein-Barr infection

时间窗: 6 months from transplant

incidence of Virus Epstein-Barr infections after allogeneic haematopoietic stem cell transplantation

Virus Epstein-Barr disease

时间窗: 6 months from transplant

incidence of Virus Epstein-Barr disease after allogeneic haematopoietic stem cell transplantation

Herpesvirus human 6 infection

时间窗: 6 months from transplant

incidence of human 6 infection after allogeneic haematopoietic stem cell transplantation

次要结局

  • Overall Survival (OS)(These outcome measures will be assessed at 1 year from transplant)
  • Disease Free Survival (DFS)(These outcome measures will be assessed at 1 year from transplant)
  • Transplant Related Mortality (TRM)(These outcome measures will be assessed at 1 year from transplant)
  • chronic graft-versus-host disease(These outcome measures will be assessed at 1 year from transplant)
  • Relapse risk (RR)(These outcome measures will be assessed at 1 year from transplant)
  • Acute Graft-versus-Host Disease(These outcome measures will be assessed at 100 days from transplant)

研究者

发起方
Gruppo Italiano Trapianto di Midollo Osseo
申办方类型
Other
责任方
Sponsor

研究点 (50)

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