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ENSAT Registry-Based Randomized Clinical Trials for Adrenocortical Carcinoma.

  • Crona J J Crona, Department of Medical Sciences, Uppsala University, Uppsala, 75185, Sweden.
  • Baudin E E Baudin, Nuclear Medicine and Endocrine Oncology, Gustave Roussy Cancer Center, Villejuif, France.
  • Terzolo M M Terzolo, San Luigi Hospital, University of Turino, Orbassano, Italy.
  • Chrisoulidou A A Chrisoulidou, Endocrinology, Theagenio Cancer Hospital, Thessaloniki, Greece.
  • Angelousi AG A Angelousi, ENDOCRINOLOGY, ETHNIKO KAI KAPODISTRIAKO UNIVERSITY OF ATHENS , ATHENS, 11527, Greece.
  • Ronchi CL C Ronchi, Institute of Metabolism and System Research, University of Birmingham, Birmingham, B152TT, United Kingdom of Great Britain and Northern Ireland.
  • Lamas C C Lamas, Endocrinology, Hospital General de Albacete, Albacete, 02006, Spain.
  • Nieveen van Dijkum E E Nieveen van Dijkum, Surgery, Amsterdam UMC - Locatie AMC, Amsterdam, Netherlands.
  • Ceccato F F Ceccato, Endocrinology Unit, Department of Medicine DIMED, University-Hospital of Padova, Padova, Italy.
  • Borson-Chazot F F Borson-Chazot, Faculte RTH Laennec, Universite Claude Bernard Lyon1, Lyon, F-69008, France.
  • Reimondo G G Reimondo, Internal Medicine, Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, University of Turin, Turin, Italy.
  • Tiberi GA G Tiberi, Surgical Clinic, Department of Clinical and Experimental Sciences, University of Brescia at ASST Spedali Civili, Brescia, Italy.
  • Ettaieb H H Ettaieb, Internal Medicine, Máxima Medical Center, Eindhoven, Netherlands.
  • Kiriakopoulos A A Kiriakopoulos, 5th Surgical Clinic, ''Evgenidion Hospital'' National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
  • Canu L L Canu, University of Florence, Department of Experimental and Clinical Biomedical Sciences "Mario Serio", Florence, Italy.
  • Kastelan D D Kastelan, Department of Internal Medicine, Division of Endocrinology, University Hospital Centre Zagreb, Zagreb, 10000, Croatia.
  • Osher E E Osher, Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  • Yiannakopoulou E E Yiannakopoulou, Department of Biomedical Sciences, Faculty of Health Sciences, University of West Attica, Athens, Greece.
  • Arnaldi G G Arnaldi, Endocrinology Units, Department of Internal Medicine, Polytechnic University of Marche Region, Division of Endocrinology, Ancona, 60126, Italy.
  • Assie G G Assie, INSERM U1016, CNRS UMR8104, Institut Cochin, Paris, 75014, France.
  • Paiva I I Paiva, Endocrinology, Hospitais da Universidade de Coimbra, Lisboa, Portugal.
  • Bourdeau I I Bourdeau, Research Center, Centre hospitalier de l'université de Montréal, Montreal, H2W 1T7, Canada.
  • Newell-Price J J Newell-Price, Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, United Kingdom of Great Britain and Northern Ireland.
  • Nowak KM K Nowak, Department of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, 01-809, Poland.
  • Romero MT M Romero, UGC Endocrinología y Nutrición, Hospital Universitario Virgen Macarena, Sevilla, Spain.
  • De Martino MC M De Martino, Dipartimento di Medicina Clinica e Chirurgia Endocrinologia e Metabolismo, Università degli Studi di Napoli Federico II, Naples, 80131, Italy.
  • Bugalho MJ M Bugalho, Endocrinology, Hospital de Santa Maria, Lisboa, Portugal.
  • Sherlock M M Sherlock, Department of Endocrinology, Beaumont Hospital and the Royal College of Surgeons in Ireland, Dublin, Ireland.
  • Vantyghem MC M Vantyghem, Nord, CHRU de lille service endocrinologie-diabetologie-maladie métabolique, Lille, 59 000, France.
  • Dennedy MC M Dennedy, Pharmacology and Therapeutics, National University of Ireland, Galway, Galway, Ireland.
  • Loli P P Loli, Endocrinology, Ospedale Niguarda Ca' Granda, Napoli, 20162, Italy.
  • Rodien P P Rodien, Endocrinologie, CHU d'Angers, Angers 49933, Angers Cedex 09, France.
  • Feelders RA R Feelders, Internal Medicine, Erasmus MC, Rotterdam, 3015 GD, Netherlands.
  • de Krijger RR R de Krijger, Princess Máxima Center for Pediatric Oncology, Princess Máxima Center for Pediatric Oncology, Rotterdam, Netherlands.
  • Van Slycke S S Van Slycke, General and Endocrine Surgery, OLV Hospital Aalst, Aalst, Belgium.
  • Aylwin S S Aylwin, King's College Hospital, King's College Hospital, London, United Kingdom of Great Britain and Northern Ireland.
  • Morelli V V Morelli, Endocrinology Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
  • Vroonen L L Vroonen, Department of Endocrinology, Centre hospitalier universitaire de Liège, Liege, Belgium.
  • Shafigullina Z Z Shafigullina, Endocrinology Department, North-Western Medical University named after I.I.Mechnikov, Saint-Petersburg, Russian Federation.
  • Bancos I I Bancos, Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, 55905, United States.
  • Trofimiuk-Müldner M M Trofimiuk-Müldner, Department of Endocrinology, Jagiellonian University Medical College, Krakow, Poland.
  • Quinkler M M Quinkler, Endocrinology in Charlottenburg, Endocrinology in Charlottenburg, Berlin, Germany.
  • Luconi M M Luconi, Dept. Experimental and Clinical Biomedical Sciences "Mario Serio", University of Florence, Firenze, Italy.
  • Kroiss M M Kroiss, Endocrine and Diabetes Unit, University Hospital Würzburg, Würzburg, 97080, Germany.
  • Naruse M M Naruse, Department of Endocrinology, Metabolism and Hypertension, National Hospital Organization Kyoto Medical Center, Kyoto, 612-8555, Japan.
  • Igaz P P Igaz, 2nd Department of Internal Medicine, Semmelweis Egyetem, Budapest, 1085, Hungary.
  • Mihai R R Mihai, Endocrine Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom of Great Britain and Northern Ireland.
  • Della Casa S S Della Casa, Division of Endocrinology and Metabolic Diseases, Institute of Medical Pathology, Universita Cattolica del Sacro Cuore Facolta di Medicina e Chirurgia, Roma, Italy.
  • Berruti A A Berruti, Department of Medical and Surgical Specialties Radiological Sciences, and Public Health, Medical Oncology, University of Brescia at ASST Spedali Civili, Brescia, 25123, Italy.
  • Fassnacht M M Fassnacht, Department of Internal Medicine I, Division of Endocrinology and Diabetes, University Hospital Würzburg, Wuerzburg, 97080, Germany.
  • Beuschlein F F Beuschlein, Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, UniversitatsSpital Zurich, Zurich, 8091, Switzerland.
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  • 2020-11-09
Published in:
  • European journal of endocrinology. - 2020
English Adrenocortical carcinoma (ACC) is an orphan disease lacking effective systemic treatment options. The low incidence of the disease and high cost of clinical trials are major obstacles in the search for improved treatment strategies. As a novel approach, registry-based clinical trials have been introduced in clinical research, so allowing for significant cost reduction, but without compromising scientific benefit. Herein, we describe how the European Network for the Study of Adrenal Tumours (ENSAT) could transform its current registry into one fit for a clinical trial infrastructure. The rationale to perform randomized registry-based trials in ACC is outlined including an analysis of relevant limitations and challenges. We summarize a survey on this concept among ENSAT members who expressed a strong interest of the concept and rated its scientific potential as high. Legal aspects, including ethical approval of registry-based randomization were identified as potential obstacles. Finally, we describe three potential randomized registry-based clinical trials in an adjuvant setting and for advanced disease with a high potential to be executed within the framework of an advanced ENSAT registry. Thus we therefore provide the basis for future registry-based trials for ACC patients. This could ultimately provide proof-of-principle of how to perform more effective randomized trials for an orphan disease.
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  • English
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green
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https://folia.unifr.ch/global/documents/10531
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