Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)
研究概览
简要总结
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
详细描述
It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.
The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).
The SRDK0921 system (kit and software) is intended:
- to calculate a score of subclinical rejection in kidney transplant patients
- as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
- •Subjects transplanted from living or deceased donors.
- •Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
- •Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
- •Subjects under standard immunosuppressive treatments.
排除标准
- •Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
- •Subjects that have stopped immunosuppressive treatments.
结局指标
主要结局
AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)
时间窗: at 1 year after kidney transplant
To determine the analytical performance meaning the discriminating ability of the IVD (kit and software), between patients displaying a sub-clinical rejection and patients without subclinical rejection, confirmed with the gold standard method (graft biopsy). An AUC ≥ 0.75 was considered as clinically acceptable.
次要结局
- Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value(at 1 year after kidney transplant)
- Quantification of the gene expression signature(at 1 year after kidney transplant)