Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
研究概览
简要总结
The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.
详细描述
Single Center Prospective Cohort Study on De-Novo Lung Transplant recipients. AlloSure will be drawn as part of routine blood draws and sent to CareDx for analysis of dd-cfDNA. All data will be collected and stored in the hospital EMR, this will be examined with the AlloSure results to correlate outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Denovo lung transplant recipient
- •Ability to understand written and spoken English
排除标准
- •Previous transplant or multi-organ transplant
- •Unable to have blood draw for medical reason
结局指标
主要结局
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
时间窗: 72 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Allograft Rejection 6 Months Post Transplant
时间窗: 6 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant
时间窗: 24 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant
时间窗: 9 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant
时间窗: 4 months post transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant
时间窗: 11 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant
时间窗: 12 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Number of Participants With Allograft Rejection 3 Months Post Transplant
时间窗: 3 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant
时间窗: pre-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant
时间窗: 72 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant
时间窗: 2 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant
时间窗: 24 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant
时间窗: 48 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Allograft Rejection 9 Months Post Transplant
时间窗: 9 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Number of Participants With Allograft Rejection 12 Months Post Transplant
时间窗: 12 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
时间窗: 10 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant
时间窗: 12 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant
时间窗: 5 months post transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant
时间窗: 6 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant
时间窗: 7 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant
时间窗: 8 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant
时间窗: 48 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
时间窗: 1 week post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant
时间窗: 3 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant
时间窗: 4 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant
时间窗: 5 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant
时间窗: 7 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant
时间窗: 6 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant
时间窗: 8 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant
时间窗: 11 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
时间窗: 10 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant
时间窗: 9 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
次要结局
- Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant(one year post transplant)
研究者
Pablo Sanchez
Vice Chair, Benign Lung Diseases Surgical Director, Lung Transplant and ECMO, Director, Lung Transplant Research and ELVP Program
University of Pittsburgh