跳至主要内容
临床试验/NCT04234919
NCT04234919已完成不适用

A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Relationship

研究概览

简要总结

Lung transplant is a viable treatment strategy for many with end-stage lung diseases. Despite advances in both the surgical and medical management, lung transplant recipients experience episodes of allograft insult and injury that lead to dysfunction and ultimately contribute to graft failure. The primary noninvasive tool for monitoring the lung allograft, pulmonary function testing, is neither sensitive nor specific for lung allograft injury which makes the management of lung transplant recipients particularly challenging. A decline in pulmonary function tests prompts invasive procedures such as bronchoscopy with transbronchial lung biopsy to diagnose the cause of allograft injury, although this, too, is not 100% sensitive, and oftentimes patients are treated empirically for rejection when no other etiology for lung function decline is identified. Empiric treatment prompted by extrapulmonary drivers of decline in lung function may result in inappropriate exposure to risks of augmented immunosuppression. The purpose of this study is to determine to what extent monitoring of donor-derived cell free DNA in lung transplant recipients can be used as a marker of lung injury and stability.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Actively listed or have recently had a double lung transplant
  • Participant is willing and able to provide informed consent

排除标准

  • Prior organ transplantation
  • Transplantation performed in the setting of hospitalization for acute illness or decompensation
  • Unable or unwilling to consent for enrolment
  • Single lung transplant recipient
  • Consideration for multi-organ transplantation
  • Pregnant women

结局指标

主要结局

Relationship

时间窗: 12 Months

Determine the relationship between donor derived cell free DNA and lung allograft function during the first year after lung transplant.

次要结局

  • Quantitative Assessments(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验