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ENSAT registry-base...
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Crona, JoakimUppsala universitet,Endokrin tumörbiologi
(author)
ENSAT registry-based randomized clinical trials for adrenocortical carcinoma
- Article/chapterEnglish2021
Publisher, publication year, extent ...
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Bioscientifica,2021
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-435488
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-435488URI
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https://doi.org/10.1530/EJE-20-0800DOI
Supplementary language notes
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Language:English
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Summary in:English
Part of subdatabase
Classification
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Subject category:ref swepub-contenttype
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Subject category:for swepub-publicationtype
Notes
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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 in 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.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Baudin, EricUniv Paris Saclay, Dept Imagerie, Serv Oncol Endocrinienne, Gustave Roussy, Villejuif, France.
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Terzolo, MassimoUniv Turin, Dept Clin & Biol Sci, San Luigi Hosp, Orbassano, Italy.
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Chrisoulidou, AlexandraTheagenio Canc Hosp, Dept Endocrinol, Thessaloniki, Greece.
(author)
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Angelousi, AnnaNatl & Kapodistrian Univ Athens, Laiko Hosp, Dept Internal Med 1, Unit Endocrinol, Athens, Greece.
(author)
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Ronchi, Cristina L.Univ Birmingham, Inst Metab & Syst Res, Birmingham, W Midlands, England.;Univ Hosp Wurzburg, Div Endocrinol & Diabet, Wurzburg, Germany.
(author)
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Oliveira, Cristina LamasComplejo Hosp Univ Albacete, Endocrinol Dept, Albacete, Spain.
(author)
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van Dijkum, Els J. M. NieveenUniv Amsterdam, Canc Ctr Amsterdam, Dept Surg, Amsterdam UMC, Amsterdam, Netherlands.
(author)
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Ceccato, FilippoUniv Hosp Padova, Dept Med DIMED, Endocrinol Unit, Padua, Italy.
(author)
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Borson-Chazot, FrancoiseUniv Claude Bernard Lyon 1, Hosp Civils Lyon, Federat Endocrinol, Lyon, France.
(author)
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Reimondo, GiuseppeUniv Turin, San Luigi Gonzaga Hosp, Dept Clin & Biol Sci, Internal Med, Turin, Italy.
(author)
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Tiberi, Guido A. M.Univ Brescia, Dept Clin & Expt Sci, Surg Clin, ASST Spedali Civili, Brescia, Italy.
(author)
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Ettaieb, HesterMaxima Med Ctr, Div Endocrinol, Dept Internal Med, Eindhoven, Netherlands.
(author)
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Kiriakopoulos, AndreasNatl & Kapodistrian Univ Athens, Surg Clin 5, Evgenid Hosp, Sch Med, Athens, Greece.
(author)
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Letizia, CanuUniv Florence, Dept Expt & Clin Biomed Sci, Florence, Italy.
(author)
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Kastelan, DarkoUniv Hosp Ctr Zagreb, Dept Endocrinol, Zagreb, Croatia.
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Osher, EsthrTel Aviv Univ, Tel Aviv Sourasky Med Ctr Israel, Inst Endocrinol Metab & Hypertens, Sackler Fac Med, Tel Aviv, Israel.
(author)
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Yiannakopoulou, EugeniaUniv West Attica, Dept Biomed Sci, Fac Hlth Sci, Athens, Greece.
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Arnaldi, GiorgioPolytech Univ Marche, Dept Clin & Mol Sci, Div Endocrinol, Ancona, Italy.
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Assie, GuillaumeUniv Paris, CNRS, Inst Cochin, INSERM, Paris, France.;Hop Cochin, AP HP, Endocrinol, Paris, France.
(author)
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Paiva, IsabelCtr Hosp & Univ Coimbra, Dept Endocrinol Diabet & Metab, Coimbra, Portugal.
(author)
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Bourdeau, IsabelleCtr Hosp Univ Montreal CHUM, Dept Med, Res Ctr, Div Endocrinol, Montreal, PQ, Canada.
(author)
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Newell-Price, JohnUniv Sheffield, Dept Oncol & Metab, Med Sch, Sheffield, S Yorkshire, England.
(author)
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Nowak, Karolina M.Bielanski Hosp, Ctr Postgrad Med Educ, Dept Endocrinol, Warsaw, Poland.
(author)
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Romero, M. TousHosp Univ Virgen Macarena, UGC Endocrinol & Nutr, Seville, Spain.
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De Martino, Maria CristinaUniv Federico II Napoli, Dipartimento Med Clin & Chirurg, Sez Endocrinol, Naples, Italy.
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Bugalho, Maria JoaoCHULN, Serv Endocrinol Diabet & Metabol, Lisbon, Portugal.;Univ Lisbon, Fac Med, Lisbon, Portugal.
(author)
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Sherlock, MarkBeaumont Hosp, Dept Endocrinol, Dublin, Ireland.;Royal Coll Surgeons Ireland, Dublin, Ireland.
(author)
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Vantyghem, Marie-ChristineLille Univ Hosp, Endocrinol Diabetol Metab & Nutr Dept, Lille, France.
(author)
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Dennedy, Michael ConallNatl Univ Ireland, Dept Endocrinol & Diabet Mellitus, Dept Med, Clin Sci Inst, Galway, Ireland.
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Loli, PaulaOsped Niguarda Ca Granda, Endocrinol, Naples, Italy.
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Rodien, PatriceCHU Angers, Serv Endocrinol Diabetol & Nutr, Angers 9, France.
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Feelders, RichardErasmus MC, Div Endocrinol, Dept Internal Med, Rotterdam, Netherlands.
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de Krijger, RonaldPrincess Maxima Ctr Pediat Oncol, Utrecht, Netherlands.;Univ Med Ctr, Dept Pathol, Utrecht, Netherlands.
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Van Slycke, SamOLV Hosp Aalst, Gen & Endocrine Surg, Aalst, Belgium.
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Aylwin, SimonKings Coll Hosp London, London, England.
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Morelli, ValentinaOsped Maggiore Policlin, Endocrinol Unit, Fdn IRCCS Ca Granda, Milan, Italy.
(author)
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Vroonen, LaurentCtr Hosp Univ Liege, Dept Endocrinol, Liege, Belgium.
(author)
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Shafigullina, ZulfiyaNorth Western Med Univ, Endocrinol Dept, St Petersburg, Russia.
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Bancos, IrinaMayo Clin, Div Endocrinol Diabet Metab & Nutr, Rochester, MN USA.
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Trofimiuk-Mueldner, MalgorzataJagiellonian Univ Med Coll, Dept Endocrinol, Krakow, Poland.
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Quinkler, MarcusEndocrinol Charlottenburg, Berlin, Germany.
(author)
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Luconi, MichaelaUniv Florence, Dept Expt & Clin Biomed Sci, Florence, Italy.
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Kroiss, MatthiasUniv Hosp Wurzburg, Div Endocrinol & Diabet, Wurzburg, Germany.;Univ Wurzburg, Comprehens Canc Ctr Mainfranken, Wurzburg, Germany.
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Naruse, MitsuhideIjinkai Takeda Gen Hosp, Endocrine Ctr, Kyoto, Japan.;NHO Kyoto Med Ctr, Clin Res Inst Endocrinol & Metab, Kyoto, Japan.
(author)
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Igaz, PeterSemmelweis Univ, Dept Internal Med 2, Budapest, Hungary.;Hungarian Acad Sci, MTA SE Mol Med Res Grp, Budapest, Hungary.;Semmelweis Univ, Budapest, Hungary.
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Mihai, RaduUniv Oxford, Dept Endocrine Surg, Churchill Canc Ctr, Oxford, England.
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Della Casa, SilviaCatholic Univ, Endocrinol Dept, Gemelli Polyclin Fdn, Rome, Italy.
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Berruti, AlfredoUniv Brescia, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Med Oncol,ASST Spedali Civili, Brescia, Italy.
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Fassnacht, MartinUniv Hosp Wurzburg, Div Endocrinol & Diabet, Wurzburg, Germany.;Univ Wurzburg, Comprehens Canc Ctr Mainfranken, Wurzburg, Germany.
(author)
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Beuschlein, FelixUniv Spital Zurich, Klin Endokrinol Diabetol & Klin Ernahrung, Zurich, Switzerland.;Klinikum Univ Munchen, Deptr Endocrinol, Med Klin & Poliklin 4, Munich, Germany.
(author)
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Uppsala universitetEndokrin tumörbiologi
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In:European Journal of Endocrinology: Bioscientifica184:2, s. R51-R590804-46431479-683X
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Crona, Joakim
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Baudin, Eric
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Terzolo, Massimo
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Chrisoulidou, Al ...
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Angelousi, Anna
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Ronchi, Cristina ...
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Oliveira, Cristi ...
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van Dijkum, Els ...
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Ceccato, Filippo
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Reimondo, Giusep ...
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Tiberi, Guido A. ...
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Ettaieb, Hester
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Kiriakopoulos, A ...
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Letizia, Canu
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Kastelan, Darko
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Osher, Esthr
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Yiannakopoulou, ...
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Arnaldi, Giorgio
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Assie, Guillaume
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Paiva, Isabel
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Nowak, Karolina ...
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Romero, M. Tous
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de Krijger, Rona ...
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Aylwin, Simon
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