Clinical trial NCT03116217: Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
Official title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Posterior Urethral Valves
Keywords: renal function
post natal
peptidome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-04-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers (18 years old and more) carrying male fetuses with suspected PUV

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Renal/patient survival at 2 years post-natally.
timeFrame: Year 2
Secondary outcomes:
measure: Renal function of the survivors at day 4 and 6 and 12 month post-natally.
timeFrame: Year 1
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bordeaux
country: France
facility: CHU Pellegrin-Bordeaux
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Bron
country: France
facility: Hôpital Femme Mère Enfant-Lyon
city: Cergy Pontoise
country: France
facility: CH René-Dubos
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique
city: Marseille
country: France
facility: CHU de la Timone
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nantes
country: France
facility: Hôpital mère-enfant pédiatrie
city: Nice
country: France
facility: CHU Lenval
city: Paris
country: France
facility: AP-HP - Hôpital Necker Enfants malades
city: Paris
country: France
facility: Hôpital Robert-Debré
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes Hôpital Sud
city: Saint Etienne
country: France
facility: CHU Hôpitaux de St-Etienne-Hôpital Nord
city: Salouel
country: France
facility: Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud
city: Schiltigheim
country: France
facility: Sihcus-Cmco
city: Talence
country: France
facility: Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)
city: Toulouse
country: France
facility: Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan
city: Tours
country: France
facility: Centre Olympe de Gouges du CHRU de Tours
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
city: Leiden
country: Netherlands
facility: Leiden University Medical Center Dept of prenatal diagnosis and therapy
state: The Netherlands
city: Nijmegen
country: Netherlands
facility: Radboudumc Amalia Children's Hospital
state: The Netherlands
city: Lodz
country: Poland
facility: Polish Mothers Memorial Hospital Research Institute
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Geneve
country: Switzerland
facility: Hôpital des Enfants Hôpitaux universitaire Genève (HUG)
state: Switserland
city: Birmingham
country: United Kingdom
facility: FetalMedicine Centre Birmingham Women's Hospital
Study officials:
affiliation: CHU Toulouse
name: Stéphane DECRAMER, Pr
role: PRINCIPAL_INVESTIGATOR
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citation: Hogan J, Dourthe ME, Blondiaux E, Jouannic JM, Garel C, Ulinski T. Renal outcome in children with antenatal diagnosis of severe CAKUT. Pediatr Nephrol. 2012 Mar;27(3):497-502. doi: 10.1007/s00467-011-2068-6. Epub 2011 Dec 14.
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