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

Posterior Urethral Valves Clinical Trial

— Antenatal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03116217
• Other study ID #: 16/8805
• Secondary ID: 2016-A01914-47
• Status: Recruiting
• Start date: June 26, 2017
• Est. completion date: December 26, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: Stéphane DECRAMER, Pr
• Phone: 5 34 55 84 58
• Email: decramer.s[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posterior Urethral Valves

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
France	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	Salouel
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
Germany	Heidelberg University Hospital	Heidelberg
Italy	Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico	Milan
Netherlands	Leiden University Medical Center Dept of prenatal diagnosis and therapy	Leiden	The Netherlands
Netherlands	Radboudumc Amalia Children's Hospital	Nijmegen	The Netherlands
Poland	Polish Mothers Memorial Hospital Research Institute	Lodz
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Switzerland	Hôpital des Enfants Hôpitaux universitaire Genève (HUG)	Geneve	Switserland
United Kingdom	FetalMedicine Centre Birmingham Women's Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

References & Publications (9)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. Erratum In: JAMA 2000 Apr 19;283(15):1963. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal/patient survival at 2 years post-natally.	Defined by the need for dialysis or death.	Year 2
Secondary	Renal function of the survivors at day 4 and 6 and 12 month post-natally.	This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis.	Year 1