Cooperative Huntington's Observational Research Trial

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

Condition or disease
Huntington Disease

Detailed Description:

COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	5000 participants
Time Perspective:	Prospective
Official Title:	Cooperative Huntington's Observational Research Trial
Study Start Date :	February 2006
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA

Blood, DNA and Urine

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

1. An individual of any age that is affected by Huntington's disease
2. An individual 18 years of age or older, who has tested positive for the HD gene
3. An individual 18 years of age or older who is a parent, sibling or child of an individual affected by HD
4. An older adolescent 15 to 17 years of age, who has a parent affected by HD enrolled in COHORT, or a parent who has tested positive for the HD gene enrolled in COHORT (at select sites)
5. Grandparents and grandchildren of anyone participating in COHORT who fulfills the requirements of (the above) category (1) or (2)
6. HD family members who have no risk for HD due to no family history (spouses or caregivers)
7. HD family members who have undergone DNA testing and does not carry the genetic mutation responsible for HD.

Criteria

Inclusion Criteria:

• (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.
• (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.
• (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
• (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
• (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.

Exclusion Criteria:

• (1) Anyone who does not fit the inclusion criteria

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Huntington Study Group	800-487-7671

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Locations

United States, Alabama
University of Alabama at Birmingham	Terminated
Birmingham, Alabama, United States
United States, California
UCLA School of Medicine	Recruiting
Los Angeles, California, United States
Contact: Angeline Gratiano 310-206-2154 agratiano@mednet.ucla.edu
University of California, Davis	Recruiting
Sacramento, California, United States
Contact: Nicole Mans 916-734-3541 nicole.mans@ucdmc.ucdavis.edu
University of California, San Diego	Recruiting
San Diego, California, United States
Contact: jody goldstein 858-622-5854 jlgoldstein@ucsd.edu
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Jonathan Gooblar, BA 415-476-1686 jgooblar@memory.ucsf.edu
United States, Colorado
Colorado Neurological Institute	Recruiting
Littleton, Colorado, United States
Contact: Diane Erickson 303-762-6674 derickson@thecni.org
United States, Connecticut
University of Connecticut	Recruiting
Hartford, Connecticut, United States
Contact: Mary Jane Fitzpatrick 860-679-4441 fitzpatrick@psychiatry.uchc.edu
Institutue for Neurodegenerative Disorders	Recruiting
New Haven, Connecticut, United States
Contact: Candace Cotto 203-401-4339 ccotto@indd.org
United States, Florida
University of Miami School of Medicine	Recruiting
Miami, Florida, United States
Contact: Monica Quesada 305-243-3647 mquesada2@med.miami.edu
University of South Florida	Recruiting
Tampa, Florida, United States
Contact: Marcia McCall 813-974-6022 mamccall@hsc.usf.edu
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States
Contact: Elaine Sperin 404-728-4786 esperin@emory.edu
Medical College of Georgia	Recruiting
Augusta, Georgia, United States
Contact: Buff Farrow 706-721-0619 bfarrow@georgiahealth.edu
United States, Illinois
Rush University Medical Center	Recruiting
Chicago, Illinois, United States
Contact: Jeana Jaglin 312-942-5003 jjaglin2@rush.edu
University of Chicago	Recruiting
Chicago, Illinois, United States
Contact: Joan Young 773-702-4392 jyoung@neurology.bsd.uchicago.edu
United States, Indiana
Indiana University School of Medicine	Recruiting
Indianapolis, Indiana, United States
Contact: Melissa Wesson 317-274-2390 mkwesson@iupi.edu
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States
Contact: Michelle Harreld 319-384-1174 michelle-harreld@uiowa.edu
United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States
Contact: Hillary Dubinsky 913-945-5019 hdubinsky@kumc.edu
Hereditary Neurological Disease Center	Recruiting
Wichita, Kansas, United States
Contact: Greg Suter 316-721-9250 hndcentre@aol.com
United States, Kentucky
University of Louisville	Recruiting
Louisville, Kentucky, United States, 40294
Contact: Annette Robinson 502-540-3585 annette.robinson@louisville.edu
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States
Contact: Claire Welsh 410-955-1349 cswelsh@jhmi.edu
University of Maryland	Recruiting
Baltimore, Maryland, United States
Contact: Lauren Doyle 410-328-3339 ldoyle@upi.umaryland.edu
United States, Massachusetts
Boston University School of Medicine	Recruiting
Boston, Massachusetts, United States
Contact: Melissa Diggin 617-638-7704 melissa.diggin@bmc.org
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States
Contact: Robert McInnis 617-723-5694 rmcinnis@partners.org
United States, Minnesota
Hennepin County Medical Center	Active, not recruiting
Minneapolis, Minnesota, United States
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States
Contact: Stacey Barton 314-362-3471 bartons@neuro.wustl.edu
United States, New York
Albany Medical College	Recruiting
Albany, New York, United States
Contact: Sharon Evans 518-262-6611 evanss@mail.amc.edu
Columbia University	Recruiting
New York, New York, United States
Contact: Ronda Clouse 212-305-2387 clouser@sergievsky.cpmc.columbia.edu
University of Rochester	Recruiting
Rochester, New York, United States
Contact: Amy Chesire 585-341-7519 amy.chesire@ctcc.rochester.edu
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States
Contact: Sarah Wyne 919-668-2837 wyne1991@duke.edu
Wake Forest University Baptist Medical Center	Recruiting
Winston Salem, North Carolina, United States
Contact: Christine O'Neill 336-716-8611 coneil@iupui.edu
United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States
Contact: Mary Beth Bialick 513-558-0018 howardb33@aol.com
The Cleveland Clinic	Recruiting
Cleveland, Ohio, United States
Contact: Christine Reece 216-445-9833 houser@ccf.org
Ohio State University	Recruiting
Columbus, Ohio, United States
Contact: Allison Seward 614-688-8672 allison.seward@osumc.edu
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States
Contact: Iman Affan 215-829-3582 iman.affan@uphs.upenn.edu
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Nancy Lucarelli 412-692-4659 lucarellina2@upmc.edu
United States, Tennessee
University of Tennessee-Memphis	Recruiting
Memphis, Tennessee, United States
Contact: Nathan Jones 901-448-6180 njones37@utmem.edu
United States, Texas
Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Giselle Huet, MS 214-648-0378 giselle.huet@utsouthwestern.edu
Contact: Amit Gode, MPH 214-648-0417 amit.gode@utsouthwestern.edu
Baylor College of Medicine	Recruiting
Houston, Texas, United States
Contact: Tiffany Reedus 713-798-7438 treedus@bcm.edu
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Paola Wall 801-581-4543 paola.wall@hsc.utah.edu
United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States
Contact: Robert Davis 434-243-5692 rbd4n@virginia.edu
United States, Washington
Booth Gardner Parkinsons Center	Recruiting
Kirkland, Washington, United States, 98034
Contact: Marsha Merrick 425-899-3115 mgmerrick@evergreenhealthcare.org
Australia, New South Wales
Westmead Hospital	Recruiting
Wentworthville, New South Wales, Australia
Contact: Jane Griffith 011-61-2-98456793 jane_griffith@wsahs.nsw.gov.au
Australia, Victoria
The University of Melbourne	Recruiting
Kew, Victoria, Australia
Contact: Bernadette Mannaa 61 3 9816 0444 ext 8114 bmannaa@unimelb.edu.au
Australia, Western Australia
Graylands, Selby-Lemnos & Special Care Health Services	Recruiting
Perth, Western Australia, Australia, 6910
Contact: Steve Andrew 618 9347 6464 steve.andrews@health.wa.gov.au
Canada, Alberta
University of Calgary Medical Clinic	Recruiting
Calgary, Alberta, Canada
Contact: Mary Lou Klimek 403-210-8548 klimek@ucalgary.ca
Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada
Contact: Allison Coleman 604-822-7739 allison@cmmt.ubc.ca
Canada, Manitoba
Movement Disorder Clinic Deer Lodge Centre	Recruiting
Winnipeg, Manitoba, Canada
Contact: Sandra Funk 204-940-8547 sfunk@mdc-dlc.ca
Movement Disorders Clinic, Deer Lodge Centre	Recruiting
Winnipeg, Manitoba, Canada
Contact: Sandra Funk 204-940-8547 sfunk@mdc-dlc.ca
Canada, Nova Scotia
Halifax Infirmary	Recruiting
Halifax, Nova Scotia, Canada, B3H1V7
Contact: Joanne Courtney-Walker 902-473-8261 joanne.walker@cdha.nshealth.ca
Canada, Ontario
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Emilija Makaji, MSC 519-685-8500 ext 36893 emilija.makaji@lhsc.on.ca
The Centre for Addiction and Mental Health	Recruiting
Markham, Ontario, Canada
Contact: Irita Karmalkar 905-472-7082 ext 229 ikarmalkar@movementdisorders.ca
Canada, Quebec
Hotel-Dieu Hospital-CHUM	Recruiting
Montreal, Quebec, Canada
Contact: Suzanne Paris 514-890-8000 ext 26511 suzanne.paris.chum@ssss.gouv.qc.ca

Sponsors and Collaborators

HP Therapeutics Foundation

Huntington Study Group

Investigators

Principal Investigator:	Ira Shoulson, MD	University of Rochester/Huntington Study Group

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.

Huntington Study Group COHORT Investigators, Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16. Erratum in: PLoS One. 2012;7(8). doi: 10.1371/annotation/25881bc7-922d-4472-9efd-f0896b1a3499.

Responsible Party:	Ira Shoulson, MD/Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier:	NCT00313495 History of Changes
Other Study ID Numbers:	COHORT
First Posted:	April 12, 2006
Last Update Posted:	March 7, 2011
Last Verified:	March 2011

Keywords provided by HP Therapeutics Foundation:

Huntington disease, observational, family members, biomarker

Additional relevant MeSH terms:

Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases	Genetic Diseases, Inborn; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Chorea; Dyskinesias