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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

400

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach

9 countries

29 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

First Submitted

Initial submission to the registry

March 10, 2017

Completed

1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2023

Completed

Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

6.5 years

First QC Date

March 10, 2017

Last Update Submit

August 22, 2023

Conditions

Posterior Urethral Valves

Keywords

renal functionpost natalpeptidome

Outcome Measures

Primary Outcomes (1)

Renal/patient survival at 2 years post-natally.
Defined by the need for dialysis or death.
Year 2

Secondary Outcomes (1)

Renal function of the survivors at day 4 and 6 and 12 month post-natally.
Year 1

Eligibility Criteria

Age18 Years - 65 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsPregnant women

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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.

You may not qualify if:

refusal to participate in the study;
person protected by law.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University Hospital, Toulouselead
Institut National de la Santé Et de la Recherche Médicale, Francecollaborator

Study Sites (29)

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

CHU Pellegrin-Bordeaux

Bordeaux, 33078, France

ACTIVE NOT RECRUITING

CHRU de Brest - Hôpital Morvan

Brest, 29609, France

ACTIVE NOT RECRUITING

Hôpital Femme Mère Enfant-Lyon

Bron, 69677, France

ACTIVE NOT RECRUITING

CH René-Dubos

Cergy-Pontoise, 95303, France

ACTIVE NOT RECRUITING

CHU Estaing

Clermont-Ferrand, 63100, France

NOT YET RECRUITING

CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique

Grenoble, 38043, France

ACTIVE NOT RECRUITING

CHU de la Timone

Marseille, 13385, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

ACTIVE NOT RECRUITING

Hôpital mère-enfant pédiatrie

Nantes, 44093, France

RECRUITING

CHU Lenval

Nice, 06200, France

NOT YET RECRUITING

AP-HP - Hôpital Necker Enfants malades

Paris, 75015, France

NOT YET RECRUITING

Hôpital Robert-Debré

Paris, 75019, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, 86021, France

ACTIVE NOT RECRUITING

CHU Rennes Hôpital Sud

Rennes, 35000, France

ACTIVE NOT RECRUITING

CHU Hôpitaux de St-Etienne-Hôpital Nord

Saint-Etienne, 42055, France

ACTIVE NOT RECRUITING

Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud

Salouël, 80480, France

ACTIVE NOT RECRUITING

Sihcus-Cmco

Schiltigheim, 67300, France

RECRUITING

Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)

Talence, 33400, France

NOT YET RECRUITING

Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan

Toulouse, 31059, France

RECRUITING

Centre Olympe de Gouges du CHRU de Tours

Tours, 37000, France

NOT YET RECRUITING

Heidelberg University Hospital

Heidelberg, 60120, Germany

NOT YET RECRUITING

Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

Leiden University Medical Center Dept of prenatal diagnosis and therapy

Leiden, The Netherlands, 2333, Netherlands

NOT YET RECRUITING

Radboudumc Amalia Children's Hospital

Nijmegen, The Netherlands, 6500, Netherlands

NOT YET RECRUITING

Polish Mothers Memorial Hospital Research Institute

Lodz, 93-338, Poland

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hôpital des Enfants Hôpitaux universitaire Genève (HUG)

Geneva, Switserland, CH-1211, Switzerland

NOT YET RECRUITING

FetalMedicine Centre Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

NOT YET RECRUITING

Related Publications (9)

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.
PMID: 22167562BACKGROUND
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.
PMID: 15343248BACKGROUND
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.
PMID: 12907115BACKGROUND
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.
PMID: 23953766BACKGROUND
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.
PMID: 10694729BACKGROUND
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.
PMID: 10493205BACKGROUND
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.
PMID: 16477057BACKGROUND
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.
PMID: 16980149BACKGROUND
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.
PMID: 23946195BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum urine

Study Officials

Stéphane DECRAMER, Pr
University Hospital, Toulouse
PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane DECRAMER, Pr

CONTACT

5 34 55 84 58 decramer.s@chu-toulouse.fr

Françoise CONTE-AURIOL

CONTACT

auriol.f@chu-toulouse.fr

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 17, 2017

Study Start

June 26, 2017

Primary Completion

December 26, 2023

Study Completion

December 26, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing: Will not share

Locations

PL(1)GB(1)ES(1)BE(1)DE(1)NL(2)IT(1)FR(20)CH(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (9)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations