Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Purpose
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.
Condition
- Huntington's Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
University of Alabama
Birmingham 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013
Phoenix 5308655, Arizona 5551752 85013
University of California - Irvine Medical Center
Irvine 5359777, California 5332921 92697
Irvine 5359777, California 5332921 92697
University of California - Los Angeles
Los Angeles 5368361, California 5332921 90095
Los Angeles 5368361, California 5332921 90095
University of California - Davis
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
University of California - San Diego
San Diego 5391811, California 5332921 92037
San Diego 5391811, California 5332921 92037
University of California - San Francisco
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Cenexel Rocky Mountain Clinical Research, LLC
Englewood 5421250, Colorado 5417618 80113
Englewood 5421250, Colorado 5417618 80113
University of Connecticut
Farmington 4834272, Connecticut 4831725 06032
Farmington 4834272, Connecticut 4831725 06032
Georgetown University
Washington D.C. 4140963, District of Columbia 4138106 20007
Washington D.C. 4140963, District of Columbia 4138106 20007
University of Florida Board of Trustees
Gainesville 4156404, Florida 4155751 32607
Gainesville 4156404, Florida 4155751 32607
University of Miami
Miami 4164138, Florida 4155751 33431
Miami 4164138, Florida 4155751 33431
University of South Florida, HDSA Center of Excellence at USF
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Emory University, Wesley Woods Health Center
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Rush University Medical Center
Chicago 4887398, Illinois 4896861 68612
Chicago 4887398, Illinois 4896861 68612
Indiana University
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
University of Iowa
Iowa City 4862034, Iowa 4862182 52245
Iowa City 4862034, Iowa 4862182 52245
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Hereditary Neurological Disease Center
Wichita 4281730, Kansas 4273857 67226
Wichita 4281730, Kansas 4273857 67226
University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48105
Ann Arbor 4984247, Michigan 5001836 48105
Hennepin County Medical Center
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55415
Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68106
Omaha 5074472, Nebraska 5073708 68106
Cleveland Clinic - Las Vegas
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Rutgers, the State University of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
New Brunswick 5101717, New Jersey 5101760 08901
Albany Medical College
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
Columbia University
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
University of Rochester
Rochester 5134086, New York 5128638 14618
Rochester 5134086, New York 5128638 14618
Duke University
Durham 4464368, North Carolina 4482348 27705
Durham 4464368, North Carolina 4482348 27705
Wake Forest School of Medicine
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
Sanford Health
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
University of Cincinatti
Cincinnati 4508722, Ohio 5165418 42519
Cincinnati 4508722, Ohio 5165418 42519
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
The Ohio State University
Columbus 4509177, Ohio 5165418 43021
Columbus 4509177, Ohio 5165418 43021
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
University of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
University of South Carolina
Columbia 4575352, South Carolina 4597040 29203
Columbia 4575352, South Carolina 4597040 29203
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Texas Health Science Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Utah
Salt Lake City 5780993, Utah 5549030 84108
Salt Lake City 5780993, Utah 5549030 84108
University of Vermont
Burlington 5234372, Vermont 5242283 05401
Burlington 5234372, Vermont 5242283 05401
University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
Virginia Commonwealth University Parkinson's and Movement Disorders Center
Henrico 4763729, Virginia 6254928 23298
Henrico 4763729, Virginia 6254928 23298
Booth Gardner Parkinson's Care Center (Evergreen Health)
Kirkland 5799841, Washington 5815135 98034
Kirkland 5799841, Washington 5815135 98034
University of Washington Medical Center
Seattle 5809844, Washington 5815135 98195
Seattle 5809844, Washington 5815135 98195
University of Wisconsin - Madison
Madison 5261457, Wisconsin 5279468 53705
Madison 5261457, Wisconsin 5279468 53705
More Details
- NCT ID
- NCT01574053
- Status
- Recruiting
- Sponsor
- CHDI Foundation, Inc.
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.