Cooperative Huntington's Observational Research Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by HP Therapeutics Foundation
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
HP Therapeutics Foundation
ClinicalTrials.gov Identifier:
NCT00313495
First received: April 10, 2006
Last updated: March 4, 2011
Last verified: March 2011
  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: Time Perspective: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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

Additional Information:
No publications provided by HP Therapeutics Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ira Shoulson, MD/Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00313495     History of Changes
Other Study ID Numbers: COHORT
Study First Received: April 10, 2006
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias

ClinicalTrials.gov processed this record on September 30, 2014