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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life. — 2 years of age
  Renal survival is defined as the absence of end-stage renal disease (ESRD) requiring dialysis by 2 years of age. Patient survival is defined as the child being alive at 2 years. Renal function is assessed through clinical follow-up, including serum creatinine measurements and estimated glomerular filtration rate (eGFR) using the Schwartz formula. Dialysis initiation is determined based on standard clinical criteria for ESRD. Survival status is confirmed through medical records and follow-up visits. This outcome aims to validate the predictive value of the 98-peptide amniotic fluid signature for postnatal kidney function in CAKUT fetuses.

Trial sites (1)

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