Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
NCT ID: NCT03116217
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
400 participants
OBSERVATIONAL
2017-06-26
2023-12-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus
NCT03356314
Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.
NCT03751397
Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
NCT02792348
Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.
NCT05148429
Retrospective Evaluation of a Cohort of Patients Diagnosed With Pre- and Postnatal Urinary Dilatation: Outcome and Long-term Follow-up
NCT06764472
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* person protected by law.
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stéphane DECRAMER, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Leuven
Leuven, , Belgium
CHU Pellegrin-Bordeaux
Bordeaux, , France
CHRU de Brest - Hôpital Morvan
Brest, , France
Hôpital Femme Mère Enfant-Lyon
Bron, , France
CH René-Dubos
Cergy-Pontoise, , France
CHU Estaing
Clermont-Ferrand, , France
CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique
Grenoble, , France
CHU de la Timone
Marseille, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Hôpital mère-enfant pédiatrie
Nantes, , France
CHU Lenval
Nice, , France
AP-HP - Hôpital Necker Enfants malades
Paris, , France
Hôpital Robert-Debré
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rennes Hôpital Sud
Rennes, , France
CHU Hôpitaux de St-Etienne-Hôpital Nord
Saint-Etienne, , France
Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud
Salouël, , France
Sihcus-Cmco
Schiltigheim, , France
Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)
Talence, , France
Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan
Toulouse, , France
Centre Olympe de Gouges du CHRU de Tours
Tours, , France
Heidelberg University Hospital
Heidelberg, , Germany
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
Milan, , Italy
Leiden University Medical Center Dept of prenatal diagnosis and therapy
Leiden, The Netherlands, Netherlands
Radboudumc Amalia Children's Hospital
Nijmegen, The Netherlands, Netherlands
Polish Mothers Memorial Hospital Research Institute
Lodz, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hôpital des Enfants Hôpitaux universitaire Genève (HUG)
Geneva, Switserland, Switzerland
FetalMedicine Centre Birmingham Women's Hospital
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Seeds JW. Diagnostic mid trimester amniocentesis: how safe? Am J Obstet Gynecol. 2004 Aug;191(2):607-15. doi: 10.1016/j.ajog.2004.05.078.
Clark TJ, Martin WL, Divakaran TG, Whittle MJ, Kilby MD, Khan KS. Prenatal bladder drainage in the management of fetal lower urinary tract obstruction: a systematic review and meta-analysis. Obstet Gynecol. 2003 Aug;102(2):367-82. doi: 10.1016/s0029-7844(03)00577-5.
Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD; Percutaneous vesicoamniotic shunting in Lower Urinary Tract Obstruction (PLUTO) Collaborative Group. Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial. Lancet. 2013 Nov 2;382(9903):1496-506. doi: 10.1016/S0140-6736(13)60992-7. Epub 2013 Aug 14.
Schmoor C, Sauerbrei W, Schumacher M. Sample size considerations for the evaluation of prognostic factors in survival analysis. Stat Med. 2000 Feb 29;19(4):441-52. doi: 10.1002/(sici)1097-0258(20000229)19:43.0.co;2-n.
Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999 Sep 15;282(11):1061-6. doi: 10.1001/jama.282.11.1061.
Rutjes AW, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ. 2006 Feb 14;174(4):469-76. doi: 10.1503/cmaj.050090.
Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006 Oct;59(10):1087-91. doi: 10.1016/j.jclinepi.2006.01.014. Epub 2006 Jul 11.
Klein J, Lacroix C, Caubet C, Siwy J, Zurbig P, Dakna M, Muller F, Breuil B, Stalmach A, Mullen W, Mischak H, Bandin F, Monsarrat B, Bascands JL, Decramer S, Schanstra JP. Fetal urinary peptides to predict postnatal outcome of renal disease in fetuses with posterior urethral valves (PUV). Sci Transl Med. 2013 Aug 14;5(198):198ra106. doi: 10.1126/scitranslmed.3005807.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-A01914-47
Identifier Type: OTHER
Identifier Source: secondary_id
16/8805
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.