Study Results
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Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2017-12-16
2068-01-31
Brief Summary
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Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.
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Detailed Description
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The European Consortium of Lipodystrophy (ECLip) consists of an association of European experts in the field of lipodystrophy. It has set up a Registry Board to implement a registry for patients with lipodystrophy using the Open Source Software OSSE (Open Source Registry System for Rare Diseases in the EU), which is a web based platform focused on a federated approach that allows to perform distributed searches which are designed to comply data protection requirements and preserve data sovereignty. To ensure data protection, medical and identifying data will be stored on two different servers both run by the Institute for Epidemiology and Medical Biometry of the University of Ulm.
Medical centers from all over the world where patients are treated with lipodystrophy are invited to join the ECLip Registry and to become ECLip Registry members. Upon registration, they can enter patient data after they have obtained local ethic committee permission and the patient in question has given written consent to this. Data entry is done at the individual locations via a web-based user interface. Identifying data are recorded directly into the identity management system. Communication between the identity management and the OSSE registry happens via a web browser.
The aim of the patient registry is to compile data on the natural history of each different sub-group of lipodystrophies, their comorbidities, treatment options used and medical and quality of life out-come for the patients. For this, the following data retrieved from regular patient visits are collected:
* Precise diagnosis including moleculargenetic results
* Clinical presentation and comorbidities
* Laboratory changes and results of diagnostic procedures
* Natural course of the disease including age at onset of disease and comorbidities
* Family history
Research within this registry can be performed by participating clinicians/researchers and third parties after a research proposal has be accepted by the responsible committee of the ECLip. The registry aims to answer the following questions
* new insights into the pathophysiology of lipodystrophy
* improve therapeutic options for the patients
* compile information material for patients, families and relevant professionals
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Sorbonne University
OTHER
University Hospital, Lille
OTHER
University of Cambridge
OTHER
Endocrinology Research Centre, Moscow
OTHER_GOV
University of Leipzig
OTHER
University of Amsterdam
OTHER
Dokuz Eylul University
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
University of Rome Tor Vergata
OTHER
University of Pisa
OTHER
University of Santiago de Compostela
OTHER
Università degli Studi del Piemonte Orientale Amedeo Avogadro
OTHER
University Hospital Muenster
OTHER
Szeged University
OTHER
Centro Hospitalar do Porto
OTHER
University Medical Centre Ljubljana
OTHER
Medical University of Vienna
OTHER
National and Kapodistrian University of Athens
OTHER
Stoffwechselzentrum St. Gallen
UNKNOWN
National Taiwan University Hospital
OTHER
Marmara University
OTHER
University of Palermo
OTHER
Attikon Hospital
OTHER
Kinderkrankenhaus auf der Bult
OTHER
Hopital Universitaire Robert-Debre
OTHER
University of Milan
OTHER
C.I. Parhon National Institute of Endocrinology
OTHER
University of Ulm
OTHER
Responsible Party
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Julia von Schnurbein
Prinicipal Investigator
Principal Investigators
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Martin Wabitsch, Prof. Dr.
Role: STUDY_CHAIR
University of Ulm
David Araujo-Vilar, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Santiago de Compostela University
Julia von Schnurbein, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Gabriele Nagel, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Camille Vatier, Dr.
Role: PRINCIPAL_INVESTIGATOR
Pierre et Marie Curie School of Medicine (Paris)
Marie-Christine Vantyghem, Prof.
Role: PRINCIPAL_INVESTIGATOR
Lille University
Giovanni Ceccarini, Dr.
Role: PRINCIPAL_INVESTIGATOR
Endocrine Unit, University Hospital of Pisa
David Savage, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge Metabolic Research Laboratories
Locations
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Medical University of Vienna
Vienna, , Austria
Lille University
Lille, , France
AP-HP Nord Université de Paris, Hôpital Universitaire Robert-Debré
Paris, , France
Pierre et Marie Curie School of Medicine, Sorbonne University
Paris, , France
Kinder-und Jugendkrankenhaus AUF DER BULT
Hanover, , Germany
Department of Internal Medicine (Endocrinology and Nephrology), University of Leipzig
Leipzig, , Germany
Med. Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster
Münster, , Germany
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, , Germany
National and Kapodistrian University of Athens
Athens, , Greece
Second Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Attikon University Hospital
Athens, , Greece
University of Szeged, Department of Internal Medicine
Szeged, , Hungary
Endocrinology Unit, Department of Clinical and Medical science, S. Orsola-Malpighi Hospital , University of Bologna
Bologna, , Italy
Policlinic University Hospital of Milan
Milan, , Italy
Universita del piemonte Orientale
Novara, , Italy
Palermo University
Palermo, , Italy
Endocrine Unit of University Hospital of Pisa
Pisa, , Italy
Tor Vergata University - Policlinico of Tor Vergata
Roma, , Italy
Academic Medical Center, University of Amsterdam
Amsterdam, , Netherlands
Abel Salazar Biomedical Sciences Institute - University of Porto
Porto, , Portugal
C. I. Parhon National Institute of Endocrinology, Bucharest, Romania
Bucharest, , Romania
Endocrinology Research Centre
Moscow, , Russia
University Medical Center Ljubljana - Clinical Institute of Medical Genetics
Ljubljana, , Slovenia
Santiago de Compostela University
Santiago de Compostela, , Spain
Stoffwechselzentrum friendlydocs
Sankt Gallen, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Marmara University, Pediatric Endocrinology and Diabetes
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University School of Medicine
Izmir, , Turkey (Türkiye)
University of Cambridge Metabolic Research Laboratories
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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von Schnurbein J, Adams C, Akinci B, Ceccarini G, D'Apice MR, Gambineri A, Hennekam RCM, Jeru I, Lattanzi G, Miehle K, Nagel G, Novelli G, Santini F, Santos Silva E, Savage DB, Sbraccia P, Schaaf J, Sorkina E, Tanteles G, Vantyghem MC, Vatier C, Vigouroux C, Vorona E, Araujo-Vilar D, Wabitsch M. European lipodystrophy registry: background and structure. Orphanet J Rare Dis. 2020 Jan 15;15(1):17. doi: 10.1186/s13023-020-1295-y.
Other Identifiers
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ECLip Registry
Identifier Type: -
Identifier Source: org_study_id
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