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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hopital Morvan
      • Bron, France, 69677
        • Active, not recruiting
        • Hôpital Femme Mère Enfant-Lyon
      • Cergy Pontoise, France, 95303
        • Active, not recruiting
        • CH Rene-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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Posterior Urethral Valves

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings