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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01914-47 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| Renal/patient survival at 2 years post-natally. | Defined by the need for dialysis or death. | Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Mothers (18 years old and more) carrying male fetuses with suspected PUV
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane DECRAMER, Pr | Contact | 5 34 55 84 58 | 33 | decramer.s@chu-toulouse.fr |
| Françoise CONTE-AURIOL | Contact | auriol.f@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane DECRAMER, Pr | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22167562 | Background | 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. | |
| 15343248 | Background | 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. |
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serum urine
| CHU Pellegrin-Bordeaux | Active, not recruiting | Bordeaux | 33078 | France |
| CHRU de Brest - Hôpital Morvan | Active, not recruiting | Brest | 29609 | France |
| Hôpital Femme Mère Enfant-Lyon | Active, not recruiting | Bron | 69677 | France |
| CH René-Dubos | Active, not recruiting | Cergy-Pontoise | 95303 | France |
| CHU Estaing | Not yet recruiting | Clermont-Ferrand | 63100 | France |
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| CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique | Active, not recruiting | Grenoble | 38043 | France |
| CHU de la Timone | Active, not recruiting | Marseille | 13385 | France |
| Centre Hospitalier Universitaire de Montpellier | Active, not recruiting | Montpellier | 34295 | France |
| Hôpital mère-enfant pédiatrie | Recruiting | Nantes | 44093 | France |
|
| CHU Lenval | Not yet recruiting | Nice | 06200 | France |
|
| AP-HP - Hôpital Necker Enfants malades | Not yet recruiting | Paris | 75015 | France |
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| Hôpital Robert-Debré | Not yet recruiting | Paris | 75019 | France |
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| CHU Poitiers | Active, not recruiting | Poitiers | 86021 | France |
| CHU Rennes Hôpital Sud | Active, not recruiting | Rennes | 35000 | France |
| CHU Hôpitaux de St-Etienne-Hôpital Nord | Active, not recruiting | Saint-Etienne | 42055 | France |
| Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud | Active, not recruiting | Salouël | 80480 | France |
| Sihcus-Cmco | Recruiting | Schiltigheim | 67300 | France |
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| Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux) | Not yet recruiting | Talence | 33400 | France |
|
| Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan | Recruiting | Toulouse | 31059 | France |
|
| Centre Olympe de Gouges du CHRU de Tours | Not yet recruiting | Tours | 37000 | France |
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| Heidelberg University Hospital | Not yet recruiting | Heidelberg | 60120 | Germany |
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| Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico | Not yet recruiting | Milan | Italy |
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| Leiden University Medical Center Dept of prenatal diagnosis and therapy | Not yet recruiting | Leiden | The Netherlands | 2333 | Netherlands |
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| Radboudumc Amalia Children's Hospital | Not yet recruiting | Nijmegen | The Netherlands | 6500 | Netherlands |
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| Polish Mothers Memorial Hospital Research Institute | Not yet recruiting | Lodz | 93-338 | Poland |
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| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| Hôpital des Enfants Hôpitaux universitaire Genève (HUG) | Not yet recruiting | Geneva | Switserland | CH-1211 | Switzerland |
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| FetalMedicine Centre Birmingham Women's Hospital | Not yet recruiting | Birmingham | B15 2TG | United Kingdom |
|
| 12907115 | Background | 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. |
| 23953766 | Background | 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. |
| 10694729 | Background | 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. |
| 10493205 | Background | 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. |
| 16477057 | Background | 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. |
| 16980149 | Background | 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. |
| 23946195 | Background | 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. |