REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

Sponsor

European Huntington's Disease Network (Other)

Overall Status

Completed

CT.gov ID

NCT01590589

Collaborator

(none)

10,000

Enrollment

140

Locations

156.9

Duration (Months)

71.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Huntington Disease Huntington's Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
REGISTRY participants Individuals with manifest HD unaffected but known to carry the HD mutation unaffected but at risk of carrying the HD mutation from HD families known not to carry the HD mutation from outside HD families acting as control research participants (e.g., spouses)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

REGISTRY-HD participants include those who are willing to participate in regular (annual) evaluations conducted by the investigators and have a diagnosis of HD, are HD mutation carriers (but who do not meet criteria for a diagnosis of HD) or persons at risk for HD (first and second degree relatives of people affected by HD), are non-HD mutation carrier relatives. Spouses of participants may take part as REGISTRY-CONTROLS.

Inclusion Criteria:

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).

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz	Graz	Austria	8036
2	Universitätsklinik Innsbruck, Neurologie	Innsbruck	Austria	6020
3	UCL-St Luc, Centre de génétique humaine	Brussels	Belgium	1200
4	Institute of Pathology and Genetics (IPG)	Gosselies	Belgium	B-6041
5	Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie	Leuven	Belgium	3000
6	Fakultní nemocnice Olomouc, Neurologická klinika	Olomouc	Czechia	772 00
7	Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK	Praha 2	Czechia	12000
8	University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology	Copenhagen Ø	Denmark	2100
9	The Family Federation of Finland Väestöliitto, Department of Medical Genetics	Helsinki	Finland	FIN-00101
10	Helsinki University Hospital, Dept. of Neurology	HUS	Finland	29
11	Kuopio University Hospital, Neurology	Kuopio	Finland	1777 PL
12	Ålands Hälso- och Sjukvård, Långvårdsenheten	Mariehamn	Finland	AX-22111
13	Oulu University Hospital (OUH), Dept. of Neurology	Oulu	Finland	FIN-90220
14	Suomen Terveystalo	Tampere	Finland	33100
15	Turku University Hospital, Dept. of Neurology	Turku	Finland	20521
16	The Finnish Parkinson Association, Suvituuli	Turku	Finland	20900
17	CHU d'Amiens - Hôpital Nord, Service de Neurologie	Amiens cedex	France	80054
18	CHU d'Angers, Service de Neurologie Charcot	Angers cedex 9	France	49933
19	Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)	Bordeaux cedex	France	33076
20	HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie	Clermont-Ferrand	France	63003
21	Hôpital Henri Mondor, Service de Neurologie	Créteil cedex	France	94010
22	Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement	Lille cedex	France	59037
23	CHU La Timone, Service de Neurologie (9e étage)	Marseille cedex 5	France	13385
24	Hôpital La Pitié Salpétrière, Génétique & Inserm U679	Paris	France	75651
25	CHU Rouen Charles Nicolle, Service de Neurologie	Rouen cedex	France	76031
26	Hôpital Civil, Service de Neurologie	Strasbourg cedex	France	67091
27	Hôpital Purpan, INSERM U825, Pôle Neurosciences	Toulouse cedex 03	France	31059
28	Universitätsklinikum Aachen, Neurologische Klinik	Aachen	Germany	52074
29	Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie	Berlin	Germany	10117
30	Ruhruniversität Bochum, Neurologie	Bochum	Germany	44791
31	Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik	Dinslaken	Germany	46539
32	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie	Dresden	Germany	01307
33	Universtität Erlangen, Abteilung für Molekulare Neurologie	Erlangen	Germany	91054
34	Universitätsklinikum Freiburg, Neurologie	Freiburg	Germany	79106
35	Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung	Hamburg	Germany	20246
36	Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover	Hannover	Germany	30625
37	Psychatrium Gruppe AöR, Haus 2/1	Heiligenhafen	Germany	23774
38	Schwerpunktpraxis Huntington, Neurologie-Psychiatrie	Itzehoe	Germany	25524
39	Praxis	Marburg	Germany	35039
40	Universität Marburg, Neurologie	Marburg	Germany	35039
41	Technische Universität München, Abteilung Neurologie	München	Germany	81675
42	Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie	Münster	Germany	48129
43	Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)	Taufkirchen	Germany	84416
44	University Hospital of Ulm, Dept. of Neurology	Ulm	Germany	89081
45	University of Bari, Dept. of Neurological and Psychiatric Sciences	Bari	Italy	70124
46	Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica	Bologna	Italy	40123
47	Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica	Brescia	Italy	25125
48	University of Florence, Dip. di Scienze Neurologiche e Psichiatriche	Florence	Italy	50134
49	Università di Genova, Dept. of Neurosciences	Genova	Italy	16132
50	Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases	Milano	Italy	20133
51	Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia	Milano	Italy	20133
52	Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17	Napoli	Italy	80131
53	Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia	Pisa	Italy	56126
54	IRCCS Neuromed, U.O. Neurogenetica	Pozzilli (IS)	Italy	86077
55	Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS	Rome	Italy	00139
56	Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale	Rome	Italy	00168
57	Medisch Spectrum Twente, Dept. of Neurology	Enschede	Netherlands	7500 KA
58	UMC Groningen, Neurology	Groningen	Netherlands	9700 RB
59	Leiden University Medical Centre (LUMC), Neurology K5-Q	Leiden	Netherlands	2300 RC
60	MUMC, Dept. Neurology	Maastricht	Netherlands	6202 AZ
61	NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk	Bergen	Norway	5009
62	Rikshospitalet, Dept. of Medical Genetics	Oslo	Norway	27
63	Ulleval University Hospital, Medical Genetics	Oslo	Norway	407
64	St. Olavs Hospital HF, Neurology	Trondheim	Norway	7006
65	Specialistic Hospital in Gdansk, Dept. of Neurology	Gdansk	Poland	80-462
66	Medical University of Silesia, Dept. of Neurology	Katowice	Poland	40-752
67	Krakowska Akademia Neurologii	Krakow	Poland	31-530
68	Poznan University of Medical Sciences, Dept. of Social Medicine	Poznan	Poland	60-806
69	Medical University of Warsaw, Dept. of Neurology	Warsaw	Poland	02-097
70	Institute of Psychiatry and Neurology, First Dept. of Neurology	Warsaw	Poland	02-957
71	Hospital de Coimbra, Neurology Dept.	Coimbra	Portugal	3004 561
72	Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.	Lisbon	Portugal	1169-050
73	Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.	Lisbon	Portugal	1649-028
74	Hospital Fernando Fonseca, Neurology Dept.	Lisbon	Portugal	2700
75	Hospital de São João, Neurology Dept.	Porto	Portugal	4000
76	Hospital Geral de Santo António, Neurology Dept.	Porto	Portugal	4000
77	Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.	Vila Real	Portugal	5000
78	Huntington's Disease Society of Russia	Moscow	Russian Federation	125367
79	Complejo Hospitalario Universitario de Albacete, Neurología	Albacete	Spain	2006
80	Hospital Infanta Cristina, Neurología	Badajoz	Spain	6080
81	Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas	Barcelona	Spain	8035
82	Hospital Clínic i Provincial, Neurología	Barcelona	Spain	8036
83	Hospital Bellvitge, Neurología	Barcelona	Spain	8907
84	Hospital General Yagüe, Neurology	Burgos	Spain	9006
85	Hospital Puerta del Mar, Neurología	Cádiz	Spain	11009
86	Centro Ramón y Cajal, Neurología	Madrid	Spain	28034
87	Fundación Jiménez Díaz, Neurology	Madrid	Spain	28040
88	Hospital Clínico de Madrid, Servicio de Neurología	Madrid	Spain	28044
89	Hospital de Fuenlabrada, Neurology	Madrid	Spain	28942
90	Hospital Virgen de la Arrixaca, Neurology	Murcia	Spain	30120
91	Hospital Central de Oviedo, Neurología	Oviedo	Spain
92	Hospital Son Dureta, Neurology	Palma de Mallorca	Spain	7014
93	Hospital Virgen del Camino, Medical Genetics	Pamplona	Spain	31008
94	Hospital Donostia. Universidad del Pais Vasco, Neurociencias	San Sebastián	Spain	20014
95	Hospital General de Segovia, Neurología	Segovia	Spain	40001
96	Hospital Universitario Virgen del Rocío, Servicio de Neurología	Sevilla	Spain	41013
97	Hospital Virgen Macarena, Neurología	Sevilla	Spain
98	Hospital Universitario Mutua de Terrassa, Neurologia - Investigación	Terrassa - Barcelona	Spain	8221
99	Hospital Virgen de la Salud, Neurology	Toledo	Spain	45004
100	Hospital La Fe, Consultas Externas de Neurología	Valencia	Spain	46026
101	Hospital Clinico Universario, Department of Neurology	Zaragoza	Spain	50009
102	Sahlgren University Hospital, Dept. of Clinical Genetics	Göteborg	Sweden	41345
103	Skåne Universitetssjukhus, Neurologiska kliniken	Lund	Sweden	22185
104	Neuroenheten Utsikten	Stockholm	Sweden	11 691
105	Karolinska University Hospital - Huddinge Division, Neurology	Stockholm	Sweden	141 86
106	Norrlands Universitet Sjukhus, Dept. of Neurology	Umeå	Sweden	901 85
107	Uppsala University Hospital, Neurology	Uppsala	Sweden	751 85
108	Neurologische Klinik des Inselspitals, Praxis	Bern	Switzerland	3006
109	CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie	Lausanne	Switzerland	1011
110	University Hospital Zurich, Dept. of Neurology	Zurich	Switzerland	8091
111	Clinical Genetics Centre, Ground Floor, Ashgrove House	Aberdeen	United Kingdom	AB25 2ZA
112	The Barberry Centre, Dept. of Psychiatry	Birmingham	United Kingdom	B15 2FG
113	Blandford Hospital	Blandford Forum	United Kingdom	DT11 7DD
114	Frenchay Hospital, Neurology Dept.	Bristol	United Kingdom	BS16 1LE
115	Cambridge Centre for Brain Repair, Forvie Site	Cambridge	United Kingdom	CB2 0PY
116	Cardiff University, Life Sciences Building	Cardiff	United Kingdom	CF10 3US
117	Ninewells Hospital and Medical School, Human Genetics Unit	Dundee	United Kingdom	DD1 9SY
118	Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics	Edinburgh	United Kingdom	EH4 2XU
119	Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology	Exeter	United Kingdom	EX2 5DW
120	Queen Margaret Hospital	Fife	United Kingdom	KY12 OSU
121	Scottish Huntington Association, Units 105/106	Glasgow	United Kingdom	G40 2DD
122	Gloucestershire Royal Hospital, Neurology Dept.	Gloucester	United Kingdom
123	Chapel Allerton Hospital, Yorkshire Regional Genetics Service	Hull	United Kingdom	LS7 4SA
124	Chapel Allerton Hospital	Leeds	United Kingdom	LS7 4SA
125	Leicestershire Partnership NHS Trust, EMD South School, OSL house	Leicester	United Kingdom	LE19 1XU
126	The Walton Centre for Neurology and Neurosurgery	Liverpool	United Kingdom	L9 7LJ
127	Guy's Hospital, Dept. of Neurology	London	United Kingdom	SE1 9RT
128	The Royal Hospital for Neuro-disability, Research and Development	London	United Kingdom	SW15 3SW
129	St George's Hospital Medical School, South West Thames Regional Genetics Unit	London	United Kingdom	SW17 0RE
130	National Hospital for Neurology and Neurosurgery, Dept. for Neurology	London	United Kingdom	WC1N 3BG
131	University of Manchester, Genetic Medicine, St. Mary's Hospital	Manchester	United Kingdom	M13 9WL
132	Institute of Human Genetics, International Centre for Life	Newcastle upon Tyne	United Kingdom	NE1 3BZ
133	Churchill Hospital, Dept. of Clinical Genetics	Oxford	United Kingdom	OX3 7LJ
134	Derriford Hospital, Dept. of Clinical Neuropsychology	Plymouth	United Kingdom	PL6 8AH
135	Poole Hospital Foundation Trust, Brain Injury Service	Poole	United Kingdom	BH15 2JB
136	Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital	Preston	United Kingdom	PR2 9HT
137	Sheffield Children's Hospital, Dept. of Clinical Genetics	Sheffield	United Kingdom	S10 2TH
138	Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility	Southampton	United Kingdom	SO16 6YD
139	Bucknall Hospital, Neuropsychiatry Service	Stoke-on-Trent	United Kingdom	ST2 8LD
140	Victoria Centre	Swindon	United Kingdom	SN3 6BW