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NCT01574053RecruitingAccepts Healthy Volunteers

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

CHDI Foundation, Inc.

Start Date

7/1/2012

Completion Date

1/1/2062

Summary

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Detailed Description

The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) 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). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With more than 150 active clinical sites in 23 countries, Enroll-HD is now the largest HD database available and is accessible to any interested researcher - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation. * Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation. These two major categories can be further subdivided into six different subgroups of eligible individuals: * Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD. * Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD. * Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status. * Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation. * Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers). * Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies. Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification. Exclusion Criteria: * Individuals who do not meet inclusion criteria, * Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation. * For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.). Participants under 18 may be eligible to participate (if they have juvenile-onset HD).

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Conditions

Huntington's Disease

Locations

University of Alabama

Birmingham, Alabama 35294

United States

St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013

United States

University of California - Irvine Medical Center

Irvine, California 92697

United States

Loma Linda Medical Center

Loma Linda, California 92354

United States

University of California - Los Angeles

Los Angeles, California 90095

United States

University of California - Davis

Sacramento, California 95817

United States

University of California - San Diego

San Diego, California 92037

United States

University of California - San Francisco

San Francisco, California 94158

United States

Cenexel Rocky Mountain Clinical Research, LLC

Englewood, Colorado 80113

United States

University of Connecticut

Farmington, Connecticut 06032

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

University of Florida Board of Trustees

Gainesville, Florida 32607

United States

University of Miami

Miami, Florida 33431

United States

University of South Florida, HDSA Center of Excellence at USF

Tampa, Florida 33612

United States

Emory University, Wesley Woods Health Center

Atlanta, Georgia 30329

United States

Georgia Health Sciences University

Augusta, Georgia 30912

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Chicago

Chicago, Illinois 60637

United States

Rush University Medical Center

Chicago, Illinois 68612

United States

University of Illinois College of Medicine at Rockford

Rockford, Illinois 61107

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52245

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Hereditary Neurological Disease Center

Wichita, Kansas 67226

United States

University of Louisville

Louisville, Kentucky 40202

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Boston University Medical Center

Boston, Massachusetts 02118

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48105

United States

Wayne State University

Detroit, Michigan 48201

United States

Hennepin County Medical Center

Minneapolis, Minnesota 55415

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68106

United States

Cleveland Clinic - Las Vegas

Las Vegas, Nevada 89102

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

Rutgers, the State University of New Jersey

New Brunswick, New Jersey 08901

United States

Albany Medical College

Albany, New York 12208

United States

Columbia University

New York, New York 10032

United States

University of Rochester

Rochester, New York 14618

United States

Duke University

Durham, North Carolina 27705

United States

Wake Forest School of Medicine

Winston-Salem, North Carolina 27157

United States

Sanford Health

Fargo, North Dakota 58122

United States

University of Cincinatti

Cincinnati, Ohio 42519

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

The Ohio State University

Columbus, Ohio 43021

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19107

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

University of South Carolina

Columbia, South Carolina 29203

United States

University of Tennessee Health Science Center

Memphis, Tennessee 38163

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Texas Health Science Center

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84108

United States

University of Vermont

Burlington, Vermont 05401

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Virginia Commonwealth University Parkinson's and Movement Disorders Center

Henrico, Virginia 23298

United States

Virginia Commonwealth University

Richmond, Virginia 23233

United States

Booth Gardner Parkinson's Care Center (Evergreen Health)

Kirkland, Washington 98034

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

University of Wisconsin - Madison

Madison, Wisconsin 53705

United States

Instituto de Neurociencias Buenos Aires (INEBA)

Buenos Aires,

Argentina

Westmead Hospital

Westmead, New South Wales 2145

Australia

Monash University

Melbourne, Victoria 3800

Australia

The Neurosciences Unit - North Metropolitan Hospital

Perth, Western Australia 6010

Australia

University of Melbourne, Royal Melbourne Hospital

Parkville, 3052

Australia

Universitatsklinik Innsbruck

Innsbruck, 6020

Austria

University Hospitals Leuven

Leuven, Vlaams-Brabant 3000

Belgium

Bruxelles - Erasme

Brussels, 1070

Belgium

Institut de Pathologie et de Génétique (IPG)

Charleroi, B-6041

Belgium

Hôpital du Beau Vallon ASBL

Saint-Servais, B-5002

Belgium

University of Calgary, Movement Disorders Program

Calgary, Alberta T2N 4N1

Canada

University of Alberta (Glenrose)

Edmonton, Alberta T5G 0B7

Canada

University of Alberta Hospital in Edmonton

Edmonton, Alberta T6G 2B7

Canada

University of British Columbia

Vancouver, British Columbia V6T 2B5

Canada

Nova Scotia Health Authority

Halifax, Nova Scotia B3H 3A7

Canada

Centre for Movement Disorders

Markham, Ontario L6B 1C9

Canada

The Ottawa Hospital

Ottawa, Ontario K1Y 4E9

Canada

North York General Hospital

Toronto, Ontario M2K 1E2

Canada

CHUM Hospital of Notre Dame

Montreal, Quebec H2L 4M1

Canada

CETRAM

Santiago,

Chile

Universidad de Antioquia, Grupo de Neurociencias

Medellín, Antioquia 51922

Colombia

Servicios Médicos MS, Clínica de Marly

Bogotá, Cundinamarca 110231

Colombia

University Hospital of Aarhus

Aarhus, 8000

Denmark

University Hospital of Copenhagen

Copenhagen, DK2100

Denmark

University Hospital of Odense

Odense, 5000

Denmark

Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie

Strasbourg, Alsace Lorraine 67098

France

CHU Amiens-Picardie

Amiens, 80054

France

CHU Angers, Centre de Référence Maladies Neurogénétiques

Angers, 49100

France

Bordeaux - Huntington Disease competencies center

Bordeaux, 33076

France

CHU Gabriel-Montpied

Clermont-Ferrand, 63003

France

Hôpital Henri Mondor, Centre d'Investigation Clinique

Créteil, 94000

France

Lille-Amiens - Huntington Disease Constituent site

Lille, 59037

France

Hôpital La Timone

Marseille, 13005

France

CHU Montpellier

Montpellier, 34295

France

Institut du Cerveau et de la Moelle Epinière

Paris, 75646

France

Hôpital Purpan, Centre d'Investigation Clinique

Toulouse, 31059

France

University Hospital Aachen

Aachen, 52074

Germany

University of Berlin

Berlin, 10117

Germany

St. Josef und St. Elisabeth Hospital

Bochum, 44791

Germany

University Hospital Carl Gustav Carus Dresden

Dresden, 1307

Germany

University Hospital Erlangen

Erlangen, 91054

Germany

University Medical Center Freiburg

Freiburg im Breisgau, 79106

Germany

Paracelsus Elena Klinik Kassel

Kassel, 34128

Germany

University Hospital Schleswig-Holstein

Lübeck, 23538

Germany

University Hospital Giessen and Marburg

Marburg, 25043

Germany

Technical University of Munich

Munich, 81675

Germany

George-Huntington-Institut GmbH

Münster, 48149

Germany

kbo-Isar-Amper-Klinikum Taufkirchen (Vils)

Taufkirchen, 84416

Germany

University Hopsital of Ulm

Ulm, 89081

Germany

University Hospital of Wuerzburg

Würzburg, 97080

Germany

Beaumont Hospital

Dublin, Republic of Ireland

Ireland

Fondazione IRCCS Istituto Neurologico Carlo Besta - Genetics

Milan, MI 20133

Italy

Bari Policlinico General Hospital

Bari, 70124

Italy

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, 40139

Italy

Università degli Studi di Genova (DINOGMI)

Genoa, 16132

Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta - Neurology

Milan, 20133

Italy

University of Naples

Naples, I-80131

Italy

Università Cattolica del Sacro Cuore

Rome, 00168

Italy

Lega Italiana Ricerca Huntington (LIRH)

Rome, 00185

Italy

Azienda Ospedaliera Sant'Andrea

Rome, 00189

Italy

University Medical Center Groningen

Groningen, 9700RB

Netherlands

Leiden University Medical Centre

Leiden, 2300 RC

Netherlands

Clinical Trial Center Maastricht B.V.

Maastricht, 6202 AZ

Netherlands

Auckland City Hospital

Auckland, 1142

New Zealand

New Zealand Brain Research Institute at University of Otago

Christchurch, 8011

New Zealand

Wellington Hospital

Wellington, 6021

New Zealand

Copernicus Podmiotem Leczniczym sp. z o.o.

Gdansk, 80-462

Poland

Krakowska Akademia Neurologii Sp. z o.o

Katowice, 40-588

Poland

Krakow - Krakowska Akademia Neurologii

Krakow, 31-505

Poland

Solumed Centrum Medyczne

Poznan, 60-529

Poland

Medical University of Warsaw

Warsaw, 02-097

Poland

Institute of Psychiatry and Neurology, Warsaw

Warsaw, 02-957

Poland

Hospital Prof Doutor Fernando Fonseca

Amadora, 2720-276

Portugal

Hospital Universitário de Coimbra

Coimbra, 3000-075

Portugal

Central Lisbon Hospital

Lisbon, 1169-050

Portugal

Hospital de Santa Maria / Instituto de Medicina Molecular

Lisbon, 1649-035

Portugal

Hospital Universitário de São João

Porto, 4200-319

Portugal

Hospital Infanta Cristina, Badajoz

Badajoz, 06080

Spain

Hospital de Cruces

Barakaldo, 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025

Spain

Hospital Mare de Déu de la Mercè

Barcelona, 08035

Spain

Fundacion Clinic per a La Recerca Biomèdica

Barcelona, 08036

Spain

Hospital Universitari de Bellvitge

Barcelona, 08907

Spain

Hospital Universitario de Burgos

Burgos, 09006

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Son Espases

Palma de Mallorca, 07120

Spain

Complejo Hospitalario de Navarra

Pamplona, 31008

Spain

Fundacion Hospital Universitario La Fe

Valencia, 46970

Spain

Siloah AG

Gümligen, 3073

Switzerland

University Hospital Zurich

Zurich, 08091

Switzerland

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon EX25DW

United Kingdom

Leicestershire Partnership

Narborough, Leicestershire LE19 4SL

United Kingdom

North Bristol NHS Trust

Bristol, UK BS10 5NB

United Kingdom

Fife Health Board

Kirkcaldy, UK KY1 2ND

United Kingdom

Betsi Cadwaladr University Health Board

Wrexham, UK LL13 7TD

United Kingdom

University of Aberdeen

Aberdeen, AB25 2ZA

United Kingdom

Birmingham and Solihull Mental Health NHS Foundation Trust

Birmingham, B15 2FG

United Kingdom

University of Cambridge

Cambridge, CB2 0PY

United Kingdom

Cardiff University

Cardiff, CF24 4HQ

United Kingdom

Tayside Health Board

Dundee, DD1 9SY

United Kingdom

Lothian Health Board

Edinburgh, EH4 2XU

United Kingdom

Greater Glasgow Health Board

Glasgow, G51 4TF

United Kingdom

Ayrshire Central Hospital

Kilmarnock, KA2 OBB

United Kingdom

NHS Forth Valley

Larbert, FK5 4WR

United Kingdom

Leeds Teaching Hospitals

Leeds, LS7 4SA

United Kingdom

The Walton Centre

Liverpool, L9 7LJ

United Kingdom

Guy's and St. Thomas's NHS Foundation Trust

London, SE1 9RT

United Kingdom

St. George's Hospital

London, SW17 0RE

United Kingdom

University College of London

London, WC1B SEH

United Kingdom

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL

United Kingdom

Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital

Newcastle upon Tyne, NE3 3XT

United Kingdom

St. Andrews Healthcare

Northampton, NN1 5DG

United Kingdom

Oxford Radcliffe Hospitals

Oxford, OX3 9DU

United Kingdom

Plymouth Hospitals NHS Trust

Plymouth, PL6 8BX

United Kingdom

Poole Hospital

Poole, BH15 2JB

United Kingdom

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN

United Kingdom

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH

United Kingdom

University Hospital Southampton

Southampton, SO16 6YD

United Kingdom

North Staffordshire Combined Healthcare NHS Trust

Stoke-on-Trent, ST4 8HH

United Kingdom

Avon and Wiltshire Mental Health Partnership

Swindon, SN3 6BW

United Kingdom