PREdiction of Chronic LUng Allograft Dysfunction
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
- 否
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)
