Retrospective Exploratory Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- dd-cfDNA range in liver transplant patients
研究概览
简要总结
Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.
详细描述
dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Age: ≥18 years
- •The patient underwent a liver transplant.
- •The patient at least has one level of dd-cfDNA documented
排除标准
- •Patient not meeting the inclusion criteria will be excluded.
结局指标
主要结局
dd-cfDNA range in liver transplant patients
时间窗: 1 year
Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with \<1-year post-transplant (PTX) and \>1-year PTX by chart review using Methodist hospital data system.
次要结局
- LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili)(1 year)
- Days post-transplant at first dd-cfDNA(1 year)
- Serum Creatinine(1 year)
- Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)(1 year)