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Cooperative Huntington's Observational Research Trial
This study is currently recruiting participants.
Verified by HP Therapeutics Foundation, October 2009
First Received: April 10, 2006   Last Updated: October 6, 2009   History of Changes
Sponsor: HP Therapeutics Foundation
Collaborator: Huntington Study Group
Information provided by: HP Therapeutics Foundation
ClinicalTrials.gov Identifier: NCT00313495
  Purpose

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
Huntington Disease

Study Type: Observational
Study Design: Prospective
Official Title: Cooperative Huntington's Observational Research Trial

Resource links provided by NLM:


Further study details as provided by HP Therapeutics Foundation:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood, DNA and Urine


Estimated Enrollment: 5000
Study Start Date: February 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313495

Contacts
Contact: Huntington Study Group 800-487-7671

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States
Contact: Donna Pendley     205-996-7865     dpendley@peds.uab.edu    
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    
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: Karen Caplan     203-401-4347     kcaplan@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
August, Georgia, United States
Contact: Buff Dill     706-721-0619     bdill@mcg.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: Anne Leserman     319-353-4307     anne-leserman@uiowa.edu    
United States, Kansas
Hereditary Neurological Disease Center Recruiting
Wichita, Kansas, United States
Contact: Greg Suter     316-721-9250     hndcentre@aol.com    
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States
Contact: Hillary Dubinsky     913-945-5019     hdubinsky@kumc.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: Allison Mitchell     410-706-5386     amitchell@peds.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: Keith Malarick     617-726-5486     kmalarick@partners.org    
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States
Contact: Dawn Radtke     612-873-2943     dawnradtke@hotmail.com    
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
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States
Contact: Christine O'Neill     336-716-8611     coneil@iupui.edu    
Duke University Medical Center Recruiting
Durham, North Carolina, United States
Contact: Sarah Wyne     919-668-2837     wyne1991@duke.edu    
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Allison Seward     614-688-8672     allison.seward@osumc.edu    
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    
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Lisa Altin     215-829-3582     lisa.altin@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
Baylor College of Medicine Recruiting
Houston, Texas, United States
Contact: Alicia Palao     713-798-3974     palao@bcm.edu    
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States
Contact: Robert Davis     434-243-5692     rbd4n@virginia.edu    
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    
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 Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Sandra Funk     204-940-8547     sfunk@mdc-dlc.ca    
Canada, Ontario
The Centre for Addiction and Mental Health Recruiting
Markham, Ontario, Canada
Contact: Adam Singer     905-472-7082 ext 229     asinger@movementdisorders.ca    
Canada, Quebec
Hotel-Dieu Hospital-CHUM Recruiting
Montreal, Quebec, Canada
Contact: Daniel Lamoureux     514-890-8000 ext 26394     neuropsychologie@hotmail.com    
Sponsors and Collaborators
HP Therapeutics Foundation
Huntington Study Group
Investigators
Principal Investigator: Ira Shoulson, MD University of Rochester/Huntington Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: University of Rochester ( Ira Shoulson, MD/Principal Investigator )
Study ID Numbers: COHORT
Study First Received: April 10, 2006
Last Updated: October 6, 2009
ClinicalTrials.gov Identifier: NCT00313495     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by HP Therapeutics Foundation:
Huntington disease, observational, family members, biomarker

Additional relevant MeSH terms:
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea
Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease

ClinicalTrials.gov processed this record on November 30, 2009