Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).
研究概览
简要总结
Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.
Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women over 15 years of age
- •Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant
- •Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent.
- •Be affiliated with a Health Insurance plan.
排除标准
- •Pregnant, parturient and/or lactating woman
- •Hemoglobin level less than or equal to 8g/dl
- •Persons of full age who are subject to a legal protection measure or who are unable to express their consent
- •Persons under the protection of justice
- •Not being able to follow the study requirements for geographical, social or psychological reasons
- •Patient refusal.
结局指标
主要结局
Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).
时间窗: 15 years
Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.
次要结局
- Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).(15 years)
- Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data(15 years)
- Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection(15 years)
- Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.(15 years)
- Assessing patient acceptability and well-being using invasive and non-invasive biomarkers(15 years)