The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart 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
- 101
- 试验地点
- 1
- 主要终点
- RNA-seq based peripheral blood assay in heart transplant recipients
研究概览
简要总结
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
详细描述
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria are eligible for enrollment as study participants:
- •Adult (≥18 years) solitary heart transplant recipient
- •Patient is willing and able to provide informed written consent
排除标准
- •Patients who meet any of these criteria are not eligible for enrollment as study participants:
- •Adult (<18 years) heart transplant recipient
- •Patient refusal to enroll in the studyc
- •Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
结局指标
主要结局
RNA-seq based peripheral blood assay in heart transplant recipients
时间窗: 3 years
Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.
次要结局
未报告次要终点
研究者
Naveen L. Pereira
Principal Investigator
Mayo Clinic