Molecular Assessment and Profiling of Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CareDx
- 入组人数
- 1,500
- 试验地点
- 49
- 主要终点
- To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA)
研究概览
简要总结
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver transplant recipients <60 days post-transplant (de-novo or re-transplant).
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 12 years or above (Gillick Competent).
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks*.
- •Multi-organ transplant recipients or dual organ transplant recipients.
- •Patients with significant needle phobia.
研究组 & 干预措施
LiverCare Surveillance
Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study
干预措施: LiverCare (Device)
结局指标
主要结局
To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA)
时间窗: 2 years of accrual and 3 years follow up
LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'
次要结局
未报告次要终点