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临床试验/NCT03967340
NCT03967340进行中(未招募)不适用

PREdiction of Chronic LUng Allograft Dysfunction

Nantes University Hospital10 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
试验地点
10
主要终点
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)

研究概览

简要总结

Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients to receive lung transplants awaiting registration on the transplant waiting list
  • Patients affiliated to a social security system
  • Patients who have given their informed consent
  • Patients weighing more than 26 kg
  • Patients over 16 years of age

排除标准

  • Pregnant or breastfeeding women
  • Patients unable to follow the protocol
  • Patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection.
  • Patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.

结局指标

主要结局

MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)

时间窗: 3 years

次要结局

  • T lymphocytes levels over time associated with CLAD(3 years)
  • Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD(3 years)
  • Transitional B lymphocytes rate over time associated with CLAD(3 years)
  • MMP-9 levels over time associated with CLAD(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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