Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Validation of the sample circuit from clinical unit to processing platforms
研究概览
简要总结
The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Validation of the sample circuit from clinical unit to processing platforms
时间窗: 12 months
Path of the biological samples (blood, urine, biopsies) to the sample processing platforms for the editing of the raw results of the blood and urine and biopsy biomarkers
Validation of a final report
时间窗: 12 months
Edition of a final numerical report of the algorithms accessible on a web support with an intelligible interpretation by clinicians and patients.
Collection of biological samples necessary for the construction of the SDI
时间窗: 12 months
Validation of the circuit for the collection of the blood, urine and biopsy samples
Validation of raw results transmission
时间窗: 12 months
The transmission of the raw results in the format necessary for the calculation of the diagnostic and/or prognostic algorithms
次要结局
- Validation of the diagnostic and/or prognostic capabilities of the SDI(12 months)
- Providing a final report of the SDI via web interfaces(12 months)