Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03553420 En recrutement

Titre

Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)

Type

Observational [Patient Registry]

Pathologie

Lipodystrophie
Lipodystrophie partielle familiale
Lipodystrophie généralisée congénitale

Phase

Promoteur

University of Ulm (Voir sur ClinicalTrials)

Date de début

décembre 2017

Date de fin

janvier 2068

Dernière mise à jour

02 décembre 2025

Résumé

Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease. 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.

Détail

Voir le détail As lipodystrophies are rare diseases subdivided into yet rarer sub-groups, research in this field requires international co-operation. 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 Fermer le détail

Etablissements

Etablissement	Contact	Statut	Actualisé
Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

- lipodystrophy

Exclusion Criteria:

Critère de non inclusion

- lipodystrophy due to anti-retroviral drugs

NCT03553420 - Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)

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