Study of the Evolution of Circulating Plasma and Urinary DNA of Renal Origin in Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Renal cell-free DNA in plasma and urine
研究概览
简要总结
It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for early identification of transplant rejection, but not for characterization, i.e., identification of the affected renal fraction of the graft.
Recently, in healthy subjects, teams have shown that it is possible to identify the tissue origin of donor-cell-free DNA, based on the epigenetic properties of circulating DNA.
CGenetix is a MedTech company developing an in vitro diagnostic medical device to identify and quantify kidney graft degradation during transplant rejection. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating renal DNA released into the blood and urine in kidney transplant patients with or without graft rejection.
详细描述
Screening Step :
As part of routine kidney transplant patient monitoring, humoral or cellular rejection may be suspected when graft function deteriorates, proteinuria increases, or antibodies against the graft appear. If rejection is suspected, and in the absence of contraindications, a graft biopsy is scheduled during a conventional inpatient or midweek hospitalization to perform a pathological examination.
Inclusion Step :
- Transplant patient follow-up stage - Nephrology-transplant consultation: Scheduling of a graft biopsy for suspected rejection.
- Patient inclusion stage in the study, corresponding to the day the solid biopsy is performed in a conventional or day hospitalization setting.
- The patient's signature of the non-objection notice and blood samples for the research to be conducted can be taken on the same day. A minimum reflection period of 6 hours has been decided for this study to allow the patient to participate in the study.
During the patient inclusion stage, a non-objection notice and written, free consent for participation in the study and the collection of biological samples signed by the patient will be collected by the coordinating investigator or the physician (declared to be trained in research). A minimum reflection period of 6 hours was set before proposing to the patient to participate in the study.
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 living with a kidney transplant
- •Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication
排除标准
- •Patients with cognitive and mental disorders rendering them unable to express their non-opposition to participation in the study
- •Not covered by a social security system.
- •Under guardianship or guardianship, or under legal protection.
- •Patients who have expressed their refusal to participate in the study
结局指标
主要结局
Renal cell-free DNA in plasma and urine
时间窗: 24 Hours
Quantification of Renal-cell-free DNA in plasma and urine exprimed in copy / mL of biological fluid
次要结局
未报告次要终点
研究者
Poulet Geoffroy
Doctor
CGenetix