NCT03116217招募中不适用
Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 29
- 主要终点
- Renal/patient survival at 2 years post-natally.
研究概览
简要总结
Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.
详细描述
The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease.
The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound;
- •megabladder confirmed in a second ultrasound;
- •collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin;
- •written informed consent.
排除标准
- •refusal to participate in the study;
- •person protected by law.
结局指标
主要结局
Renal/patient survival at 2 years post-natally.
时间窗: Year 2
Defined by the need for dialysis or death.
次要结局
- Renal function of the survivors at day 4 and 6 and 12 month post-natally.(Year 1)
研究者
研究点 (29)
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