Posterior Urethral ValvesAntenatalNCT03116217
Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
An observational study of Posterior Urethral Valves, run by University Hospital, Toulouse at 29 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Posterior Urethral Valves
- How many people
- 400 participants
- Where
- 29 sitesin 9 countries
- Study dates
- 26 Jun 2017to 26 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Mothers (18 years old and more) carrying male fetuses with suspected PUV
Who may be able to join
- 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.
Who cannot join
- refusal to participate in the study;
- person protected by law.
Trial locations and contacts
29 sites in 9 countries.
Françoise CONTE-AURIOL contact
29 sites in 9 countries
France20 sites, 9 recruiting
- Active, not recruiting
CHU Pellegrin-Bordeaux
Bordeaux, 33078
- Active, not recruiting
CHRU de Brest - Hôpital Morvan
Brest, 29609
- Active, not recruiting
Hôpital Femme Mère Enfant-Lyon
Bron, 69677
- Active, not recruiting
CH René-Dubos
Cergy-Pontoise, 95303
- Not yet recruiting
CHU Estaing
Clermont-Ferrand, 63100
Helene LAURICHESSE, Dr, 4 73 75 01 56 ext. 33, helaurichesse@chu-clermontferrand.fr
Helene LAURICHESSE, Dr
- Active, not recruiting
CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique
Grenoble, 38043
- Active, not recruiting
CHU de la Timone
Marseille, 13385
- Active, not recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
- Recruiting
Hôpital mère-enfant pédiatrie
Nantes, 44093
Norbert WINER, Dr, 2 40 08 31 76 ext. 33, norbert.winer@chu-nantes.fr
Norbert WINER, Dr
- Not yet recruiting
CHU Lenval
Nice, 06200
Elizabeth SIMON, Dr, 4 92 03 08 09 ext. 33, Elisabeth.SIMON@lenval.com
Elizabeth SIMON, Dr
- Not yet recruiting
AP-HP - Hôpital Necker Enfants malades
Paris, 75015
Yves VILLE, Pr, 1 71 39 65 01 ext. 33, yves.ville@nck.aphp.fr
Yves VILLE, Pr
- Not yet recruiting
Hôpital Robert-Debré
Paris, 75019
Jonathan ROSENBLATT, Dr, 1 40 03 47 15 ext. 33, jonathan.rosenblatt@aphp.fr
Jonathan ROSENBLATT, Dr
- Active, not recruiting
CHU Poitiers
Poitiers, 86021
- Active, not recruiting
CHU Rennes Hôpital Sud
Rennes, 35000
- Active, not recruiting
CHU Hôpitaux de St-Etienne-Hôpital Nord
Saint-Etienne, 42055
- Active, not recruiting
Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud
Salouël, 80480
- Recruiting
Sihcus-Cmco
Schiltigheim, 67300
Romain FAVRE, Pr, 3 69 55 34 44 ext. 33, romain.favre@chru-strasbourg.fr
Romain FAVRE, Pr
- Not yet recruiting
Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)
Talence, 33400
Anne PARIS, Dr, 5 57 12 36 54 ext. 33, a.paris@mspb.com
Anne PARIS, Dr
- Recruiting
Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan
Toulouse, 31059
Stéphane Decramer, Pr, 5 34 55 86 64 ext. 33, decramer.s@chu-toulouse.fr
Stéphane DECRAMER, Pr
- Not yet recruiting
Centre Olympe de Gouges du CHRU de Tours
Tours, 37000
Franck PERROTIN, Pr, 2 47 47 47 39 ext. 33, f.perrotin@chu-tours.fr
Franck PERROTIN, Pr
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Leiden University Medical Center Dept of prenatal diagnosis and therapy
Leiden, The Netherlands, 2333
Dick Oepkes, 71 5262896 ext. 31, d.oepkes@lumc.nl
Dick Oepkes
- Not yet recruiting
Radboudumc Amalia Children's Hospital
Nijmegen, The Netherlands, 6500
Wout Feitz, Pr, 243613735 ext. 31, wout.feitz@radboudumc.nl
Wout Feitz, Pr
Belgium1 site, 1 recruiting
- Not yet recruiting
UZ Leuven
Leuven, 3000
An Hindryckx, 16341729 ext. 32, an.hindryckx@uzleuven.be
An Hindryckx
Germany1 site, 1 recruiting
- Not yet recruiting
Heidelberg University Hospital
Heidelberg, 60120
Franz Schaefer, 6221-56-32396 ext. 49, franz.schaefer@med.uni-heidelberg.de
Franz Schaefer
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
Milan
Nicola Persico, 328 5433367 ext. 39, nicola.persico@gmail.com
Nicola Persico
Poland1 site, 1 recruiting
- Not yet recruiting
Polish Mothers Memorial Hospital Research Institute
Lodz, 93-338
Marcin Tkaczyk, Pr, 42 2711391 ext. 48, mtkaczyk@uni.lodz.pl
Marcin Tkaczyk, Pr
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Gema Ariceta, 934893082 ext. 34, gariceta@vhebron.net
Gema Ariceta
Switzerland1 site, 1 recruiting
- Not yet recruiting
Hôpital des Enfants Hôpitaux universitaire Genève (HUG)
Geneva, Switserland, CH-1211
Paloma Parvex, Pr, 22795532596 ext. 41, paloma.parvex@hcuge.ch
Paloma Pervex, Pr
United Kingdom1 site, 1 recruiting
- Not yet recruiting
FetalMedicine Centre Birmingham Women's Hospital
Birmingham, B15 2TG
Katie Morris, Dr, 121 627 6652 ext. 44, r.k.morris@bham.ac.uk
Katie Morris, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Posterior Urethral Valves
- Keywords
- renal function, post natal, peptidome
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal/patient survival at 2 years post-natally.
Defined by the need for dialysis or death.
Measured: Year 2
Secondary outcomes (1)
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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start26 Jun 2017
- Primary completion26 Dec 2023 (estimated)
- Study completion26 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Posterior Urethral ValvesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane DECRAMER, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116217
- Sponsor's protocol ID
- 16/8805
- Other IDs
- 2016-A01914-47
- Acronym
- Antenatal
- Status last verified
- Aug 2023
- First submitted
- 10 Mar 2017
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22167562Seeds 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.
PubMed 15343248Clark 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.
PubMed 12907115Morris 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.
PubMed 23953766Schmoor 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.
PubMed 10694729Lijmer 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.
PubMed 10493205Rutjes 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.
PubMed 16477057Donders 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.
PubMed 16980149Klein 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.
PubMed 23946195
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
- ClinicalTrials.gov ID
- NCT03116217
- Acronym / sponsor ID
- Antenatal / 16/8805
- Conditions
- Posterior Urethral Valves
- Keywords
- renal function, post natal, peptidome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 26 Dec 2023 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers (18 years old and more) carrying male fetuses with suspected PUV
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- refusal to participate in the study;
- person protected by law.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal/patient survival at 2 years post-natally.
Time frame: Year 2
Defined by the need for dialysis or death.
1 secondary outcome
Renal function of the survivors at day 4 and 6 and 12 month post-natally.
Time frame: Year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 22167562Hogan 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.
- Background: PubMed 15343248Seeds 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.
- Background: PubMed 12907115Clark 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.
- Background: PubMed 23953766Morris 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.
- Background: PubMed 10694729Schmoor 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.
- Background: PubMed 10493205Lijmer 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.
- Background: PubMed 16477057Rutjes 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.
- Background: PubMed 16980149Donders 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.
- Background: PubMed 23946195Klein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise CONTE-AURIOL contact
Stéphane DECRAMER, Pr principal investigator
University Hospital, Toulouse
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Urethral Valves, run by University Hospital, Toulouse at 29 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Netherlands, Belgium, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane DECRAMER, Pr (5 34 55 84 58 ext. 33, decramer.s@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal/patient survival at 2 years post-natally. (time frame: Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116217, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.