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临床试验/NCT04558333
NCT04558333终止不适用

CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
1
主要终点
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.

研究概览

简要总结

Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.

详细描述

At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.

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

  • all lung transplant recipients > 18 years signed ICF (informed consent form)

排除标准

  • 未提供

结局指标

主要结局

identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.

时间窗: up to 520 weeks

death

次要结局

  • Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.(from transplantation till 72 hours after surgery)

研究者

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

Therese Lapperre

Prof. Dr. Lapperre

University Hospital, Antwerp

研究点 (1)

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