The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
研究概览
简要总结
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
详细描述
The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
- •Patients with increased risk of rejection. Patients must meet at least one of the following criteria:
- •Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
- •Recipients of donation-after-cardiac death (DCD) donors
- •Recipients of simultaneous liver-kidney transplantation
- •Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).
排除标准
- •Adult ( ≥ = 18 years) renal transplant recipient.
结局指标
主要结局
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
时间窗: 3 years
The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed.
次要结局
- To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.(3 years)