Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Recruiting

• Conditions: Posterior Urethral Valves

• Registration Number: NCT03116217
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Study Start: 2017-06-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

• refusal to participate in the study;
• person protected by law.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal/patient survival at 2 years post-natally.	Year 2	Defined by the need for dialysis or death.

Secondary Outcome Measures

Name	Time	Method
Renal function of the survivors at day 4 and 6 and 12 month post-natally.	Year 1	This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis.

Trial Locations

Locations (29)

UZ Leuven; 🇧🇪 Leuven, Belgium

CHU Pellegrin-Bordeaux; 🇫🇷 Bordeaux, France

CHRU de Brest - Hôpital Morvan; 🇫🇷 Brest, France

Hôpital Femme Mère Enfant-Lyon; 🇫🇷 Bron, France

CH René-Dubos; 🇫🇷 Cergy Pontoise, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique; 🇫🇷 Grenoble, France

CHU de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France

Hôpital mère-enfant pédiatrie; 🇫🇷 Nantes, France

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