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Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations

NCT06912490 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-04

No results posted yet for this study

Summary

The aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. It includes the feasibility of collecting, transporting and analyzing the amniotic fluid peptidome from clinical centers all over France and of providing the result in a clinically accepted time-frame. Therefore, this multicenter study will not only allow to determine the added value of such new prenatal test but also to ensure the feasibility of its introduction in the management of CAKUT pregnancies.

Conditions

Interventions

OTHER

Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)

This intervention consists of analyzing the amniotic fluid proteome using capillary electrophoresis coupled with mass spectrometry (CE-MS). The goal is to evaluate a predefined 98-peptide signature that predicts postnatal kidney function in fetuses with bilateral congenital anomalies of the kidney and urinary tract. Unlike standard prenatal assessments based on ultrasound and fetal biochemistry, this method provides a molecular-based prognostic tool to improve decision-making regarding pregnancy management and neonatal care

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2029-12-20
Completion
2029-12-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912490 on ClinicalTrials.gov