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

August 22, 2023 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • An Hindryckx
        • Sub-Investigator:
          • Luc De Catte
  • France
      • Bordeaux, France, 33078
        • Active, not recruiting
        • CHU Pellegrin-Bordeaux
      • Brest, France, 29609
        • Active, not recruiting
        • CHRU de Brest - Hôpital Morvan
      • Bron, France, 69677
        • Active, not recruiting
        • Hôpital Femme Mère Enfant-Lyon
      • Cergy Pontoise, France, 95303
        • Active, not recruiting
        • CH René-Dubos
      • Clermont-Ferrand, France, 63100
        • Not yet recruiting
        • CHU Estaing
        • Contact:
        • Principal Investigator:
          • Helene LAURICHESSE, Dr
        • Principal Investigator:
          • D. GALLOT, Pr
        • Sub-Investigator:
          • Lucie BESSENAY, Dr
      • Grenoble, France, 38043
        • Active, not recruiting
        • CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique
      • Marseille, France, 13385
        • Active, not recruiting
        • CHU de la Timone
      • Montpellier, France, 34295
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Montpellier
      • Nantes, France, 44093
        • Recruiting
        • Hôpital mère-enfant pédiatrie
        • Contact:
        • Principal Investigator:
          • Norbert Winer, Dr
        • Sub-Investigator:
          • Emma ALLAIN-LAUNEY, Dr
      • Nice, France, 06200
        • Not yet recruiting
        • CHU Lenval
        • Contact:
        • Principal Investigator:
          • Elizabeth SIMON, Dr
        • Sub-Investigator:
          • Jean BREAUD, Pr
      • Paris, France, 75015
        • Not yet recruiting
        • AP-HP - Hôpital Necker Enfants malades
        • Contact:
        • Principal Investigator:
          • Yves VILLE, Pr
        • Sub-Investigator:
          • Thomas BLANC, Dr
        • Sub-Investigator:
          • Laurence HEIDET, Pr
      • Paris, France, 75019
        • Not yet recruiting
        • Hôpital Robert-Debré
        • Contact:
        • Principal Investigator:
          • Jonathan ROSENBLATT, Dr
        • Sub-Investigator:
          • Véronique BAUDOIN, Dr
        • Sub-Investigator:
          • Georges DESCHENES, Pr
      • Poitiers, France, 86021
        • Active, not recruiting
        • CHU Poitiers
      • Rennes, France, 35000
        • Active, not recruiting
        • CHU Rennes Hôpital Sud
      • Saint Etienne, France, 42055
        • Active, not recruiting
        • CHU Hôpitaux de St-Etienne-Hôpital Nord
      • Salouel, France, 80480
        • Active, not recruiting
        • Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud
      • Schiltigheim, France, 67300
        • Recruiting
        • Sihcus-Cmco
        • Contact:
        • Principal Investigator:
          • Romain FAVRE, Pr
        • Sub-Investigator:
          • Raphael MOOG, Chirurgien
      • Talence, France, 33400
        • Not yet recruiting
        • Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)
        • Contact:
        • Principal Investigator:
          • Anne PARIS, Dr
        • Sub-Investigator:
          • Eric DOBREMEZ, Pr
        • Sub-Investigator:
          • Marie-Françoise FROUTE, Dr
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan
        • Contact:
        • Principal Investigator:
          • Stéphane DECRAMER, Pr
        • Sub-Investigator:
          • Christophe VAYSSIERES, Pr
        • Sub-Investigator:
          • Agnès SARTOR, Dr
      • Tours, France, 37000
        • Not yet recruiting
        • Centre Olympe de Gouges du CHRU de Tours
        • Contact:
        • Principal Investigator:
          • Franck PERROTIN, Pr
        • Sub-Investigator:
          • Sylvie CLOAREC, Dr
  • Germany
      • Heidelberg, Germany, 60120
        • Not yet recruiting
        • Heidelberg University Hospital
        • Contact:
        • Principal Investigator:
          • Franz Schaefer
        • Sub-Investigator:
          • Michael Elsässer
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
        • Contact:
        • Principal Investigator:
          • Nicola Persico
        • Sub-Investigator:
          • Gianantonio Manzoni
        • Sub-Investigator:
          • Giovanni Montini
  • Netherlands
    • The Netherlands
      • Leiden, The Netherlands, Netherlands, 2333
        • Not yet recruiting
        • Leiden University Medical Center Dept of prenatal diagnosis and therapy
        • Contact:
        • Principal Investigator:
          • Dick Oepkes
        • Sub-Investigator:
          • Phebe Adama van Scheltema
      • Nijmegen, The Netherlands, Netherlands, 6500
        • Not yet recruiting
        • Radboudumc Amalia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Wout Feitz, Pr
        • Sub-Investigator:
          • Barbara Kortmann, Dr
        • Sub-Investigator:
          • Michiel Schreuder, Dr
        • Sub-Investigator:
          • Frank Vandenbussche, Pr
  • Poland
      • Lodz, Poland, 93-338
        • Not yet recruiting
        • Polish Mothers Memorial Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Marcin Tkaczyk, Pr
        • Sub-Investigator:
          • Krzysztof Szaflik, Pr
        • Sub-Investigator:
          • Justyna Wojtera, MD
        • Sub-Investigator:
          • Małgorzata Stańczyk, MD PhD
        • Sub-Investigator:
          • Tomasz Talar, MD PhD
        • Sub-Investigator:
          • Barbara Pawłowska, MD PhD
        • Sub-Investigator:
          • Jerzy Guzowski, MD PhD
        • Sub-Investigator:
          • Dariusz Olejniczak, MD PhD
        • Sub-Investigator:
          • Sławomir Chrul, MD PhD
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Gema Ariceta
        • Sub-Investigator:
          • Elena Carreras
        • Sub-Investigator:
          • Silvia Arevalo
        • Sub-Investigator:
          • Carlota Rodo
  • Switzerland
    • Switserland
      • Geneve, Switserland, Switzerland, CH-1211
        • Not yet recruiting
        • Hôpital des Enfants Hôpitaux universitaire Genève (HUG)
        • Contact:
        • Principal Investigator:
          • Paloma Pervex, Pr
        • Sub-Investigator:
          • Jaques Birraux, Dr
        • Sub-Investigator:
          • Gianmaria Pellegrinelli, Dr
        • Sub-Investigator:
          • Hassib Chehade, Dr
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TG
        • Not yet recruiting
        • FetalMedicine Centre Birmingham Women's Hospital
        • Contact:
        • Principal Investigator:
          • Katie Morris, Dr
        • Sub-Investigator:
          • Mark David Kilby, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Mothers (18 years old and more) carrying male fetuses with suspected PUV

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal/patient survival at 2 years post-natally.
Time Frame: Year 2
Defined by the need for dialysis or death.
Year 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Stéphane DECRAMER, Pr, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Estimated)

December 26, 2023

Study Completion (Estimated)

December 26, 2023

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16/8805
  • 2016-A01914-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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