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临床试验/NCT07347353
NCT07347353已完成不适用

Molecular HistoMx Assessment for Kidney Transplant Rejection and Management

Paris Translational Research Center for Organ Transplantation2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice

研究概览

简要总结

Transcriptomic analysis of kidney biopsies has demonstrated the potential to improve diagnosis of graft rejection. Molecular assessment of kidney graft rejection based on the Banff Human Organ Transplant consensus gene panel is an available and validated tool (HistoMx). However the applicability of molecular assessment of graft biopsy in real life setting is unclear. The main objective is to assess the clinical need of molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice. The secondary objectives are to measure : clinical outcomes at 12-months follow up including patient survival, graft function and graft survival, diagnosis of graft rejection after integrating molecular assessment to standard histology, biology and immunology, and to evaluate therapeutic changes and impact on clinical outcome.

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

入选标准

  • Kidney recipients older than 18 years of age
  • Patients receiving a kidney transplant from a living or brain-dead donor

排除标准

  • Patients who have received a previous transplant with an organ other than the kidney
  • Patients without available graft biopsy material for molecular HistoMx testing

研究组 & 干预措施

Kidney transplant recipients from two referral academic center were enrolled in the study

干预措施: No intervention (Other)

结局指标

主要结局

Number of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice

时间窗: 12 months

The main objective is to assess the clinical indication and rate of participants with molecular assessment of kidney graft biopsy for diagnosis in real world clinical practice

次要结局

  • Graft function at 12 months after graft biopsy(12 months)

研究者

发起方
Paris Translational Research Center for Organ Transplantation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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