1. The ANTENATAL multicentre study to predict postnatal renal outcome in fetuses with posterior urethral valves: objectives and design
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Buffin-Meyer, Bénédicte, Klein, Julie, van der Zanden, Loes F M, Levtchenko, Elena, Moulos, Panogiotis, Lounis, Nadia, Conte-Auriol, Françoise, Hindryckx, An, Wühl, Elke, Persico, Nicola, Oepkes, Dick, Schreuder, Michiel F, Tkaczyk, Marcin, Ariceta, Gema, Fossum, Magdalena, Parvex, Paloma, Feitz, Wout, Olsen, Henning, Montini, Giovanni, Decramer, Stéphane, Schanstra, Joost P, De Catte, Luc, Vayssieres, Christophe, Sartor, Agnès, Groussolles, Marion, Plard, Christelle, Guerby, Paul, Connan, Laure, Morin, Mathieu, Simon, Elizabeth, Breaud, Jean, Saliou, Anne-Hélène, De Parscau, Loic, Jay, Nadine, Germouty, Isabelle, Le Bouar, Gwenaelle, Ryckewaert, Amelie, Manca-Pellissier, Marie-Christine, Merrot, Thierry, Laurichesse, Helene, Gallot, Denis, Bessenay, Lucie, Bidat, Laurent, Boize, Philippe, Winer, Norbert, Allain-Launey, Emma, Le Vaillant, Claudine, Prieur, Fabienne, Lavocat, Marie-Pierre, Coatleven, Frederic, Debromez, Eric, Harembat, Jérôme, Llanas, Brigitte, Favre, Romain, Moog, Raphael, Zaloszyc, Ariane, Massardier, Jérôme, Demede, Delphine, Perrotin, Franck, Cloarec, Sylvie, Vequeau-Goua, Valérie, Descombes, Emmanuelle, Boulot, Pierre, Morin, Denis, Fuchs, Florent, Tenenbaum, Julie, Ville, Yves, Blanc, Thomas, Heidet, Laurence, Paris, Anne, Dobremez, Eric, Froute, Marie-Françoise, Gondry, Jean, Muszynski, Charles, Haraux, Elodie, Lobelle, Fabienne, Chevreau, Julien, Rosenblatt, Jonathan, Baudoin, Véronique, Deschenes, Georges, Guigue, Virginie, Amblard, Florence, Bourdat-Michel, Guylhène, Schaefer, Franz, Elsässer, Michael, Rossi, Federica, Manzoni, Gianantonio, De Marco, Erika A, Capone, Valentina, Caforio, Leonardo, Zaccara, Antonio, Innocenzi, Michele, Bagolan, Pietro, Capozza, Nicola, Castagnetti, Marco, Mancini, Mariangela, van Scheltema, Phebe Adama, Kortmann, Barbara, Schreuder, Michiel, Stańczyk, Małgorzata, Szaflik, Krzysztof, Wojtera, Justyna, Krzeszowski, Waldemar, Talar, Tomasz, Pawłowska, Barbara, Fortecka-Piestrzeniewicz, Katarzyna, Olejniczak, Dariusz, Arevalo, Silvia, Rodo, Carlota, Lindgren, Peter, Chehade, Hassib, ANTENATAL Consortium, Hindryckx, A., De Catte, L., Vayssieres, C., Sartor, A., Groussolles, M., Plard, C., Guerby, P., Connan, L., Morin, M., Simon, E., Breaud, J., Saliou, A.H., De Parscau, L., Jay, N., Germouty, I., Le Bouar, G., Ryckewaert, A., Manca-Pellissier, M.C., Merrot, T., Laurichesse, H., Gallot, D., Bessenay, L., Bidat, L., Boize, P., Winer, N., Allain-Launey, E., Le Vaillant, C., Prieur, F., Lavocat, M.P., Coatleven, F., Debromez, E., Harembat, J., Llanas, B., Favre, R., Moog, R., Zaloszyc, A., Massardier, J., Demede, D., Perrotin, F., Cloarec, S., Vequeau-Goua, V., Descombes, E., Boulot, P., Morin, D., Fuchs, F., Tenenbaum, J., Ville, Y., Blanc, T., Heidet, L., Paris, A., Dobremez, E., Froute, M.F., Gondry, J., Muszynski, C., Haraux, E., Lobelle, F., Chevreau, J., Rosenblatt, J., Baudoin, V., Deschenes, G., Guigue, V., Amblard, F., Bourdat-Michel, G., Wühl, E., Schaefer, F., Elsässer, M., Persico, N., Rossi, F., Manzoni, G., De Marco, E.A., Montini, G., Capone, V., Caforio, L., Zaccara, A., Innocenzi, M., Bagolan, P., Capozza, N., Castagnetti, M., Mancini, M., Oepkes, D., van Scheltema, P.A., Feitz, W., Kortmann, B., Schreuder, M., Tkaczyk, M., Stańczyk, M., Szaflik, K., Wojtera, J., Krzeszowski, W., Talar, T., Pawłowska, B., Fortecka-Piestrzeniewicz, K., Olejniczak, D., Ariceta, G., Arevalo, S., Rodo, C., Fossum, M., Lindgren, P., Parvex, P., Chehade, H., Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Radboud University Medical Center [Nijmegen], Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), HybridStat Predictive Analytics [Athens, Greece], Centre d'investigation clinique de Toulouse (CIC 1436), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), University Hospitals Leuven [Leuven], Heidelberg University Hospital [Heidelberg], University of Milan, Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico [Milan, Italy], Leiden University Medical Center (LUMC), Radboud Institute for Molecular Life Sciences [Nijmegen, the Netherlands], Polish Mother’s Memorial Hospital Research Institute [Lodz] (ICZMP), Pediatric Nephrology [Barcelona, Spain] (Vall d’Hebron Hospital), Universitat Autònoma de Barcelona (UAB)-Vall d'Hebron University Hospital [Barcelona], Karolinska University Hospital [Stockholm], Karolinska Institutet [Stockholm], Geneva University Hospital (HUG), Aarhus University Hospital, Aarhus University [Aarhus], Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, ANTENATAL Consortium: An Hindryckx, Luc De Catte, Christophe Vayssieres, Agnès Sartor, Marion Groussolles, Christelle Plard, Paul Guerby, Laure Connan, Mathieu Morin, Elizabeth Simon, Jean Breaud, Anne-Hélène Saliou, Loic De Parscau, Nadine Jay, Isabelle Germouty, Gwenaelle Le Bouar, Amelie Ryckewaert, Marie-Christine Manca-Pellissier, Thierry Merrot, Helene Laurichesse, Denis Gallot, Lucie Bessenay, Laurent Bidat, Philippe Boize, Norbert Winer, Emma Allain-Launey, Claudine Le Vaillant, Fabienne Prieur, Marie-Pierre Lavocat, Frederic Coatleven, Eric Debromez, Jérôme Harembat, Brigitte Llanas, Romain Favre, Raphael Moog, Ariane Zaloszyc, Jérôme Massardier, Delphine Demede, Franck Perrotin, Sylvie Cloarec, Valérie Vequeau-Goua, Emmanuelle Descombes, Pierre Boulot, Denis Morin, Florent Fuchs, Julie Tenenbaum, Yves Ville, Thomas Blanc, Laurence Heidet, Anne Paris, Eric Dobremez, Marie-Françoise Froute, Jean Gondry, Charles Muszynski, Elodie Haraux, Fabienne Lobelle, Julien Chevreau, Jonathan Rosenblatt, Véronique Baudoin, Georges Deschenes, Virginie Guigue, Florence Amblard, Guylhène Bourdat-Michel, Elke Wühl, Franz Schaefer, Michael Elsässer, Nicola Persico, Federica Rossi, Gianantonio Manzoni, Erika A De Marco, Giovanni Montini, Valentina Capone, Leonardo Caforio, Antonio Zaccara, Michele Innocenzi, Pietro Bagolan, Nicola Capozza, Marco Castagnetti, Mariangela Mancini, Dick Oepkes, Phebe Adama van Scheltema, Wout Feitz, Barbara Kortmann, Michiel Schreuder, Marcin Tkaczyk, Małgorzata Stańczyk, Krzysztof Szaflik, Justyna Wojtera, Waldemar Krzeszowski, Tomasz Talar, Barbara Pawłowska, Katarzyna Fortecka-Piestrzeniewicz, Dariusz Olejniczak, Gema Ariceta, Silvia Arevalo, Carlota Rodo, Magdalena Fossum, Peter Lindgren, Paloma Parvex, Hassib Chehade., Schanstra, Joost, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Pôle Santé publique et médecine publique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and Università degli Studi di Milano = University of Milan (UNIMI)
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Posterior urethral valve ,medicine.medical_specialty ,Urinary system ,[SDV]Life Sciences [q-bio] ,kidney disease ,prenatal biomarkers ,Renal function ,Prenatal care ,030204 cardiovascular system & hematology ,DIAGNOSIS ,03 medical and health sciences ,All institutes and research themes of the Radboud University Medical Center ,0302 clinical medicine ,Medicine ,obstructive uropathy ,Obstructive uropathy ,development ,030304 developmental biology ,RISK ,0303 health sciences ,Transplantation ,Kidney ,ddc:618 ,Science & Technology ,business.industry ,Obstetrics ,Original Articles ,prediction ,Urology & Nephrology ,Omics ,medicine.disease ,6. Clean water ,3. Good health ,[SDV] Life Sciences [q-bio] ,Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10] ,Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11] ,medicine.anatomical_structure ,Nephrology ,embryonic structures ,Settore MED/20 ,URINARY-TRACT OBSTRUCTION ,Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] ,business ,Life Sciences & Biomedicine ,Kidney disease - Abstract
Altres ajuts: The study is partially made possible by support of the 'Programme Hospitalier de Recherche Clinique and 'La Foundation de la Recherche Médicale (grant number DEQ20170336759, France). M.T. was supported by the Polish Mothers Memorial Hospital Research Institute (internal grant number 2016/IV/54-GW. LvdZ is supported by a Kolff grant from the Dutch Kidney Foundation (13OKJ36) and a ZonMW-VENI grant from the Netherlands Organisation for Scientific Research (91618036). This project has been supported by ERN ERKNet and ERN eUROGEN, which are partly co-funded by the European Union within the framework of the Third Health Programme 'ERN-2016-Framework Partnership Agreement 2017-2021'. Posterior urethral valves (PUV) account for 17% of paediatric end-stage renal disease. A major issue in the management of PUV is prenatal prediction of postnatal renal function. Fetal ultrasound and fetal urine biochemistry are currently employed for this prediction, but clearly lack precision. We previously developed a fetal urine peptide signature that predicted in utero with high precision postnatal renal function in fetuses with PUV. We describe here the objectives and design of the prospective international multicentre ANTENATAL (multicentre validation of a fetal urine peptidome-based classifier to predict postnatal renal function in posterior urethral valves) study, set up to validate this fetal urine peptide signature. Participants will be PUV pregnancies enrolled from 2017 to 2021 and followed up until 2023 in >30 European centres endorsed and supported by European reference networks for rare urological disorders (ERN eUROGEN) and rare kidney diseases (ERN ERKNet). The endpoint will be renal/patient survival at 2 years postnatally. Assuming α = 0.05, 1-β = 0.8 and a mean prevalence of severe renal outcome in PUV individuals of 0.35, 400 patients need to be enrolled to validate the previously reported sensitivity and specificity of the peptide signature. In this largest multicentre study of antenatally detected PUV, we anticipate bringing a novel tool to the clinic. Based on urinary peptides and potentially amended in the future with additional omics traits, this tool will be able to precisely quantify postnatal renal survival in PUV pregnancies. The main limitation of the employed approach is the need for specialized equipment. Accurate risk assessment in the prenatal period should strongly improve the management of fetuses with PUV.
- Published
- 2020