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Trial record 2 of 5 for:    "Posterior Urethral Valves"

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

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ClinicalTrials.gov Identifier: NCT03116217
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease
Posterior Urethral Valves

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : December 26, 2023
Estimated Study Completion Date : December 26, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Renal/patient survival at 2 years post-natally. [ Time Frame: Year 2 ]
    Defined by the need for dialysis or death.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
serum urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mothers (18 years old and more) carrying male fetuses with suspected PUV
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116217


Contacts
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Contact: Stéphane DECRAMER, Pr 5 34 55 84 58 ext 33 decramer.s@chu-toulouse.fr
Contact: Françoise CONTE-AURIOL auriol.f@chu-toulouse.fr

Locations
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Belgium
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: An Hindryckx    16341729 ext 32    an.hindryckx@uzleuven.be   
Principal Investigator: An Hindryckx         
Sub-Investigator: Luc De Catte         
France
CHU Pellegrin-Bordeaux Active, not recruiting
Bordeaux, France, 33078
CHRU de Brest - Hôpital Morvan Active, not recruiting
Brest, France, 29609
Hôpital Femme Mère Enfant-Lyon Active, not recruiting
Bron, France, 69677
CH René-Dubos Active, not recruiting
Cergy Pontoise, France, 95303
CHU Estaing Not yet recruiting
Clermont-Ferrand, France, 63100
Contact: Helene LAURICHESSE, Dr    4 73 75 01 56 ext 33    helaurichesse@chu-clermontferrand.fr   
Principal Investigator: Helene LAURICHESSE, Dr         
Principal Investigator: D. GALLOT, Pr         
Sub-Investigator: Lucie BESSENAY, Dr         
CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique Active, not recruiting
Grenoble, France, 38043
CHU de la Timone Active, not recruiting
Marseille, France, 13385
Centre Hospitalier Universitaire de Montpellier Active, not recruiting
Montpellier, France, 34295
Hôpital mère-enfant pédiatrie Recruiting
Nantes, France, 44093
Contact: Norbert WINER, Dr    2 40 08 31 76 ext 33    norbert.winer@chu-nantes.fr   
Principal Investigator: Norbert WINER, Dr         
Sub-Investigator: Emma ALLAIN-LAUNEY, Dr         
CHU Lenval Not yet recruiting
Nice, France, 06200
Contact: Elizabeth SIMON, Dr    4 92 03 08 09 ext 33    Elisabeth.SIMON@lenval.com   
Principal Investigator: Elizabeth SIMON, Dr         
Sub-Investigator: Jean BREAUD, Pr         
AP-HP - Hôpital Necker Enfants malades Not yet recruiting
Paris, France, 75015
Contact: Yves VILLE, Pr    1 71 39 65 01 ext 33    yves.ville@nck.aphp.fr   
Principal Investigator: Yves VILLE, Pr         
Sub-Investigator: Thomas BLANC, Dr         
Sub-Investigator: Laurence HEIDET, Pr         
Hôpital Robert-Debré Not yet recruiting
Paris, France, 75019
Contact: Jonathan ROSENBLATT, Dr    1 40 03 47 15 ext 33    jonathan.rosenblatt@aphp.fr   
Principal Investigator: Jonathan ROSENBLATT, Dr         
Sub-Investigator: Véronique BAUDOIN, Dr         
Sub-Investigator: Georges DESCHENES, Pr         
CHU Poitiers Active, not recruiting
Poitiers, France, 86021
CHU Rennes Hôpital Sud Active, not recruiting
Rennes, France, 35000
CHU Hôpitaux de St-Etienne-Hôpital Nord Active, not recruiting
Saint Etienne, France, 42055
Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud Active, not recruiting
Salouel, France, 80480
Sihcus-Cmco Recruiting
Schiltigheim, France, 67300
Contact: Romain FAVRE, Pr    3 69 55 34 44 ext 33    romain.favre@chru-strasbourg.fr   
Principal Investigator: Romain FAVRE, Pr         
Sub-Investigator: Raphael MOOG, Chirurgien         
Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux) Not yet recruiting
Talence, France, 33400
Contact: Anne PARIS, Dr    5 57 12 36 54 ext 33    a.paris@mspb.com   
Principal Investigator: Anne PARIS, Dr         
Sub-Investigator: Eric DOBREMEZ, Pr         
Sub-Investigator: Marie-Françoise FROUTE, Dr         
Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan Recruiting
Toulouse, France, 31059
Contact: Stéphane Decramer, Pr    5 34 55 86 64 ext 33    decramer.s@chu-toulouse.fr   
Principal Investigator: Stéphane DECRAMER, Pr         
Sub-Investigator: Christophe VAYSSIERES, Pr         
Sub-Investigator: Agnès SARTOR, Dr         
Centre Olympe de Gouges du CHRU de Tours Not yet recruiting
Tours, France, 37000
Contact: Franck PERROTIN, Pr    2 47 47 47 39 ext 33    f.perrotin@chu-tours.fr   
Principal Investigator: Franck PERROTIN, Pr         
Sub-Investigator: Sylvie CLOAREC, Dr         
Germany
Heidelberg University Hospital Not yet recruiting
Heidelberg, Germany, 60120
Contact: Franz Schaefer    6221-56-32396 ext 49    franz.schaefer@med.uni-heidelberg.de   
Principal Investigator: Franz Schaefer         
Sub-Investigator: Michael Elsässer         
Italy
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy
Contact: Nicola Persico    328 5433367 ext 39    nicola.persico@gmail.com   
Principal Investigator: Nicola Persico         
Sub-Investigator: Gianantonio Manzoni         
Sub-Investigator: Giovanni Montini         
Netherlands
Leiden University Medical Center Dept of prenatal diagnosis and therapy Not yet recruiting
Leiden, The Netherlands, Netherlands, 2333
Contact: Dick Oepkes    71 5262896 ext 31    d.oepkes@lumc.nl   
Principal Investigator: Dick Oepkes         
Sub-Investigator: Phebe Adama van Scheltema         
Radboudumc Amalia Children's Hospital Not yet recruiting
Nijmegen, The Netherlands, Netherlands, 6500
Contact: Wout Feitz, Pr    243613735 ext 31    wout.feitz@radboudumc.nl   
Principal Investigator: Wout Feitz, Pr         
Sub-Investigator: Barbara Kortmann, Dr         
Sub-Investigator: Michiel Schreuder, Dr         
Sub-Investigator: Frank Vandenbussche, Pr         
Poland
Polish Mothers Memorial Hospital Research Institute Not yet recruiting
Lodz, Poland, 93-338
Contact: Marcin Tkaczyk, Pr    42 2711391 ext 48    mtkaczyk@uni.lodz.pl   
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
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Contact: Gema Ariceta    934893082 ext 34    gariceta@vhebron.net   
Principal Investigator: Gema Ariceta         
Sub-Investigator: Elena Carreras         
Sub-Investigator: Silvia Arevalo         
Sub-Investigator: Carlota Rodo         
Switzerland
Hôpital des Enfants Hôpitaux universitaire Genève (HUG) Not yet recruiting
Geneve, Switserland, Switzerland, CH-1211
Contact: Paloma Parvex, Pr    22795532596 ext 41    paloma.parvex@hcuge.ch   
Principal Investigator: Paloma Pervex, Pr         
Sub-Investigator: Jaques Birraux, Dr         
Sub-Investigator: Gianmaria Pellegrinelli, Dr         
Sub-Investigator: Hassib Chehade, Dr         
United Kingdom
FetalMedicine Centre Birmingham Women's Hospital Not yet recruiting
Birmingham, United Kingdom, B15 2TG
Contact: Katie Morris, Dr    121 627 6652 ext 44    r.k.morris@bham.ac.uk   
Principal Investigator: Katie Morris, Dr         
Sub-Investigator: Mark David Kilby, Pr         
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Stéphane DECRAMER, Pr CHU Toulouse

Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03116217     History of Changes
Other Study ID Numbers: 16/8805
2016-A01914-47 ( Other Identifier: ID-RCB )
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
renal function
post natal
peptidome