Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- 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 脽2-microglobulin;
- written informed consent.
- 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)
CHU Pellegrin-Bordeaux
馃嚝馃嚪Bordeaux, France
CHU de la Timone
馃嚝馃嚪Marseille, France
H么pital m猫re-enfant p茅diatrie
馃嚝馃嚪Nantes, France
UZ Leuven
馃嚙馃嚜Leuven, Belgium
CHRU de Brest - H么pital Morvan
馃嚝馃嚪Brest, France
H么pital Femme M猫re Enfant-Lyon
馃嚝馃嚪Bron, France
CH Ren茅-Dubos
馃嚝馃嚪Cergy Pontoise, France
CHU Estaing
馃嚝馃嚪Clermont-Ferrand, France
CHU de Grenoble - H么pital Couple-Enfant - D茅partement de la G茅n茅tique
馃嚝馃嚪Grenoble, France
Centre Hospitalier Universitaire de Montpellier
馃嚝馃嚪Montpellier, France
CHU Lenval
馃嚝馃嚪Nice, France
AP-HP - H么pital Necker Enfants malades
馃嚝馃嚪Paris, France
CHU Poitiers
馃嚝馃嚪Poitiers, France
CHU Rennes H么pital Sud
馃嚝馃嚪Rennes, France
CHU H么pitaux de St-Etienne-H么pital Nord
馃嚝馃嚪Saint Etienne, France
Centre hospitalier universitaire Chu Amiens Salou毛l H么pital sud
馃嚝馃嚪Salouel, France
Sihcus-Cmco
馃嚝馃嚪Schiltigheim, France
H么pital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)
馃嚝馃嚪Talence, France
Heidelberg University Hospital
馃嚛馃嚜Heidelberg, Germany
Fondazione IRCCS C脿 Granda, Ospedale Maggiore Policlinico
馃嚠馃嚬Milan, Italy
Radboudumc Amalia Children's Hospital
馃嚦馃嚤Nijmegen, The Netherlands, Netherlands
Polish Mothers Memorial Hospital Research Institute
馃嚨馃嚤Lodz, Poland
FetalMedicine Centre Birmingham Women's Hospital
馃嚞馃嚙Birmingham, United Kingdom
H么pital Robert-Debr茅
馃嚝馃嚪Paris, France
Centre Olympe de Gouges du CHRU de Tours
馃嚝馃嚪Tours, France
Leiden University Medical Center Dept of prenatal diagnosis and therapy
馃嚦馃嚤Leiden, The Netherlands, Netherlands
H么pital des Enfants H么pitaux universitaire Gen猫ve (HUG)
馃嚚馃嚟Geneve, Switserland, Switzerland
H么pital Paule de Viguier-H么pital des enfants- Site Purpan
馃嚝馃嚪Toulouse, France
Hospital Universitari Vall d'Hebron
馃嚜馃嚫Barcelona, Spain