REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)
- Conditions
- Huntington DiseaseHuntington's Disease
- Registration Number
- NCT01590589
- Lead Sponsor
- European Huntington's Disease Network
- Brief Summary
This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to:
* obtain natural history data on many HD mutation carriers and individuals who are part of an HD family
* relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)
* expedite identification and recruitment of participants for clinical trials
* develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care
* plan for future research studies
- Detailed Description
REGISTRY integrates prospectively and systematically collected clinical research data (e.g. phenotypical clinical features, family history, demographical characteristics) with access to biological specimens (e.g. blood, urine) obtained from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g. spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation).
REGISTRY is an open-ended study and eligible subjects are assessed at annual study visits on the phenotypical characteristics of HD regardless of whether they display clinical symptoms and signs of the disease and of individuals who are part of an HD family (irrespective of their mutation carrier status). At each study visit, general clinical, motor function, behavior, cognitive, Health Economics, Quality of Life assessments are administered. In addition, participants are given the option to consent to the donation of biosamples for the purposes of mutation (CAG repeat length) testing and for research to identify biological modifiers and markers of HD. Biological specimens and phenotypical data are made available to qualified scientists whose projects are reviewed and approved by the Scientific and Bioethical Advisory Committee (SBAC) of EHDN. Successful applicants agree to accept the EHDN policies surrounding the use of the data/materials provided and publication of results (see data sharing and publication policies of EHDN, attached). Research projects should aim to advance scientific knowledge towards establishing clinically effective treatments that delay onset and/or slow the progression of the disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10000
The following individuals may be eligible to participate
- Individuals, confirmed HD mutation carrier
- Manifest HD, without mutation (CAG) testing
- HD family member at-risk, without CAG testing
- HD family member, non-HD mutation carrier
- REGISTRY-CONTROL participants: companion/individual without HD history
- REGISTRY-COMPANION (any of the above).
- Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
- Participants with choreic movement disorder other than HD. (EHDN provides a Registry-like tool to record findings in patients affected with choreatic movement disorders other than HD under the label "Neuroacanthocytosis"; www.euro-hd.net/html/na/registry).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phenotypical characteristics of HD 13 years The goal of the project is to collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (140)
CHU Rouen Charles Nicolle, Service de Neurologie
🇫🇷Rouen cedex, France
Hôpital Civil, Service de Neurologie
🇫🇷Strasbourg cedex, France
Hôpital Purpan, INSERM U825, Pôle Neurosciences
🇫🇷Toulouse cedex 03, France
Ruhruniversität Bochum, Neurologie
🇩🇪Bochum, Germany
Universitätsklinikum Freiburg, Neurologie
🇩🇪Freiburg, Germany
Universitätsklinikum Aachen, Neurologische Klinik
🇩🇪Aachen, Germany
Praxis
🇩🇪Marburg, Germany
Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie
🇩🇪Berlin, Germany
Psychatrium Gruppe AöR, Haus 2/1
🇩🇪Heiligenhafen, Germany
Schwerpunktpraxis Huntington, Neurologie-Psychiatrie
🇩🇪Itzehoe, Germany
Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)
🇩🇪Taufkirchen, Germany
University Hospital of Ulm, Dept. of Neurology
🇩🇪Ulm, Germany
University of Bari, Dept. of Neurological and Psychiatric Sciences
🇮🇹Bari, Italy
Università di Genova, Dept. of Neurosciences
🇮🇹Genova, Italy
Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17
🇮🇹Napoli, Italy
Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale
🇮🇹Rome, Italy
University of Florence, Dip. di Scienze Neurologiche e Psichiatriche
🇮🇹Florence, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia
🇮🇹Milano, Italy
IRCCS Neuromed, U.O. Neurogenetica
🇮🇹Pozzilli (IS), Italy
UMC Groningen, Neurology
🇳🇱Groningen, Netherlands
Medisch Spectrum Twente, Dept. of Neurology
🇳🇱Enschede, Netherlands
NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk
🇳🇴Bergen, Norway
Leiden University Medical Centre (LUMC), Neurology K5-Q
🇳🇱Leiden, Netherlands
MUMC, Dept. Neurology
🇳🇱Maastricht, Netherlands
Rikshospitalet, Dept. of Medical Genetics
🇳🇴Oslo, Norway
St. Olavs Hospital HF, Neurology
🇳🇴Trondheim, Norway
Specialistic Hospital in Gdansk, Dept. of Neurology
🇵🇱Gdansk, Poland
Medical University of Warsaw, Dept. of Neurology
🇵🇱Warsaw, Poland
Institute of Psychiatry and Neurology, First Dept. of Neurology
🇵🇱Warsaw, Poland
Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.
🇵🇹Lisbon, Portugal
Hospital de São João, Neurology Dept.
🇵🇹Porto, Portugal
Poznan University of Medical Sciences, Dept. of Social Medicine
🇵🇱Poznan, Poland
Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.
🇵🇹Vila Real, Portugal
Hospital Bellvitge, Neurología
🇪🇸Barcelona, Spain
Hospital de Coimbra, Neurology Dept.
🇵🇹Coimbra, Portugal
Hospital Infanta Cristina, Neurología
🇪🇸Badajoz, Spain
Huntington's Disease Society of Russia
🇷🇺Moscow, Russian Federation
Hospital Fernando Fonseca, Neurology Dept.
🇵🇹Lisbon, Portugal
Hospital Son Dureta, Neurology
🇪🇸Palma de Mallorca, Spain
Hospital Clínico de Madrid, Servicio de Neurología
🇪🇸Madrid, Spain
Hospital de Fuenlabrada, Neurology
🇪🇸Madrid, Spain
Centro Ramón y Cajal, Neurología
🇪🇸Madrid, Spain
Hospital Virgen de la Arrixaca, Neurology
🇪🇸Murcia, Spain
Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas
🇪🇸Barcelona, Spain
Hospital Clínic i Provincial, Neurología
🇪🇸Barcelona, Spain
Fundación Jiménez Díaz, Neurology
🇪🇸Madrid, Spain
Hospital Central de Oviedo, Neurología
🇪🇸Oviedo, Spain
Hospital Virgen del Camino, Medical Genetics
🇪🇸Pamplona, Spain
Hospital Universitario Virgen del Rocío, Servicio de Neurología
🇪🇸Sevilla, Spain
Hospital Virgen de la Salud, Neurology
🇪🇸Toledo, Spain
Hospital La Fe, Consultas Externas de Neurología
🇪🇸Valencia, Spain
Hospital Donostia. Universidad del Pais Vasco, Neurociencias
🇪🇸San Sebastián, Spain
Hospital Virgen Macarena, Neurología
🇪🇸Sevilla, Spain
Hospital Clinico Universario, Department of Neurology
🇪🇸Zaragoza, Spain
Sahlgren University Hospital, Dept. of Clinical Genetics
🇸🇪Göteborg, Sweden
Neuroenheten Utsikten
🇸🇪Stockholm, Sweden
The Barberry Centre, Dept. of Psychiatry
🇬🇧Birmingham, United Kingdom
Frenchay Hospital, Neurology Dept.
🇬🇧Bristol, United Kingdom
Scottish Huntington Association, Units 105/106
🇬🇧Glasgow, United Kingdom
Leicestershire Partnership NHS Trust, EMD South School, OSL house
🇬🇧Leicester, United Kingdom
Guy's Hospital, Dept. of Neurology
🇬🇧London, United Kingdom
Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK
🇨🇿Praha 2, Czechia
Hôpital La Pitié Salpétrière, Génétique & Inserm U679
🇫🇷Paris, France
CHU d'Angers, Service de Neurologie Charcot
🇫🇷Angers cedex 9, France
The Finnish Parkinson Association, Suvituuli
🇫🇮Turku, Finland
Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement
🇫🇷Lille cedex, France
Universitätsklinik Innsbruck, Neurologie
🇦🇹Innsbruck, Austria
Turku University Hospital, Dept. of Neurology
🇫🇮Turku, Finland
Hôpital Henri Mondor, Service de Neurologie
🇫🇷Créteil cedex, France
CHU La Timone, Service de Neurologie (9e étage)
🇫🇷Marseille cedex 5, France
Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik
🇩🇪Dinslaken, Germany
Universtität Erlangen, Abteilung für Molekulare Neurologie
🇩🇪Erlangen, Germany
Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universität Marburg, Neurologie
🇩🇪Marburg, Germany
Technische Universität München, Abteilung Neurologie
🇩🇪München, Germany
Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica
🇮🇹Brescia, Italy
Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia
🇮🇹Pisa, Italy
Krakowska Akademia Neurologii
🇵🇱Krakow, Poland
Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung
🇩🇪Hamburg, Germany
UCL-St Luc, Centre de génétique humaine
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie
🇧🇪Leuven, Belgium
University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology
🇩🇰Copenhagen Ø, Denmark
The Family Federation of Finland Väestöliitto, Department of Medical Genetics
🇫🇮Helsinki, Finland
Kuopio University Hospital, Neurology
🇫🇮Kuopio, Finland
Ålands Hälso- och Sjukvård, Långvårdsenheten
🇫🇮Mariehamn, Finland
Suomen Terveystalo
🇫🇮Tampere, Finland
CHU d'Amiens - Hôpital Nord, Service de Neurologie
🇫🇷Amiens cedex, France
Complejo Hospitalario Universitario de Albacete, Neurología
🇪🇸Albacete, Spain
Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz
🇦🇹Graz, Austria
Institute of Pathology and Genetics (IPG)
🇧🇪Gosselies, Belgium
Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)
🇫🇷Bordeaux cedex, France
HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie
🇫🇷Clermont-Ferrand, France
Fakultní nemocnice Olomouc, Neurologická klinika
🇨🇿Olomouc, Czechia
Helsinki University Hospital, Dept. of Neurology
🇫🇮HUS, Finland
Oulu University Hospital (OUH), Dept. of Neurology
🇫🇮Oulu, Finland
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
🇩🇪Dresden, Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie
🇩🇪Münster, Germany
Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica
🇮🇹Bologna, Italy
Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS
🇮🇹Rome, Italy
Ulleval University Hospital, Medical Genetics
🇳🇴Oslo, Norway
Medical University of Silesia, Dept. of Neurology
🇵🇱Katowice, Poland
Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.
🇵🇹Lisbon, Portugal
Hospital Geral de Santo António, Neurology Dept.
🇵🇹Porto, Portugal
Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases
🇮🇹Milano, Italy
Hospital General Yagüe, Neurology
🇪🇸Burgos, Spain
Hospital General de Segovia, Neurología
🇪🇸Segovia, Spain
Skåne Universitetssjukhus, Neurologiska kliniken
🇸🇪Lund, Sweden
Uppsala University Hospital, Neurology
🇸🇪Uppsala, Sweden
Neurologische Klinik des Inselspitals, Praxis
🇨🇭Bern, Switzerland
University Hospital Zurich, Dept. of Neurology
🇨🇭Zurich, Switzerland
Clinical Genetics Centre, Ground Floor, Ashgrove House
🇬🇧Aberdeen, United Kingdom
Queen Margaret Hospital
🇬🇧Fife, United Kingdom
Chapel Allerton Hospital, Yorkshire Regional Genetics Service
🇬🇧Hull, United Kingdom
The Walton Centre for Neurology and Neurosurgery
🇬🇧Liverpool, United Kingdom
Churchill Hospital, Dept. of Clinical Genetics
🇬🇧Oxford, United Kingdom
Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility
🇬🇧Southampton, United Kingdom
Bucknall Hospital, Neuropsychiatry Service
🇬🇧Stoke-on-Trent, United Kingdom
Victoria Centre
🇬🇧Swindon, United Kingdom
St George's Hospital Medical School, South West Thames Regional Genetics Unit
🇬🇧London, United Kingdom
Chapel Allerton Hospital
🇬🇧Leeds, United Kingdom
Hospital Puerta del Mar, Neurología
🇪🇸Cádiz, Spain
Hospital Universitario Mutua de Terrassa, Neurologia - Investigación
🇪🇸Terrassa - Barcelona, Spain
Norrlands Universitet Sjukhus, Dept. of Neurology
🇸🇪Umeå, Sweden
Blandford Hospital
🇬🇧Blandford Forum, United Kingdom
Cardiff University, Life Sciences Building
🇬🇧Cardiff, United Kingdom
Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology
🇬🇧Exeter, United Kingdom
Gloucestershire Royal Hospital, Neurology Dept.
🇬🇧Gloucester, United Kingdom
Derriford Hospital, Dept. of Clinical Neuropsychology
🇬🇧Plymouth, United Kingdom
Poole Hospital Foundation Trust, Brain Injury Service
🇬🇧Poole, United Kingdom
Karolinska University Hospital - Huddinge Division, Neurology
🇸🇪Stockholm, Sweden
CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie
🇨🇭Lausanne, Switzerland
Cambridge Centre for Brain Repair, Forvie Site
🇬🇧Cambridge, United Kingdom
Ninewells Hospital and Medical School, Human Genetics Unit
🇬🇧Dundee, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital
🇬🇧Preston, United Kingdom
Sheffield Children's Hospital, Dept. of Clinical Genetics
🇬🇧Sheffield, United Kingdom
University of Manchester, Genetic Medicine, St. Mary's Hospital
🇬🇧Manchester, United Kingdom
Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics
🇬🇧Edinburgh, United Kingdom
The Royal Hospital for Neuro-disability, Research and Development
🇬🇧London, United Kingdom
Institute of Human Genetics, International Centre for Life
🇬🇧Newcastle upon Tyne, United Kingdom
National Hospital for Neurology and Neurosurgery, Dept. for Neurology
🇬🇧London, United Kingdom