Cooperative Huntington's Observational Research Trial

March 4, 2011 updated by: HP Therapeutics Foundation
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huntington Study Group
  • Phone Number: 800-487-7671

Study Locations

  • Australia
    • New South Wales
      • Wentworthville, New South Wales, Australia
    • Victoria
      • Kew, Victoria, Australia
        • Recruiting
        • The University of Melbourne
        • Contact:
    • Western Australia
      • Perth, Western Australia, Australia, 6910
        • Recruiting
        • Graylands, Selby-Lemnos & Special Care Health Services
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • University of Calgary Medical Clinic
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • University of British Columbia
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Recruiting
        • Movement Disorder Clinic Deer Lodge Centre
        • Contact:
      • Winnipeg, Manitoba, Canada
        • Recruiting
        • Movement Disorders Clinic, Deer Lodge Centre
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
      • Markham, Ontario, Canada
    • Quebec
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Terminated
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
        • Recruiting
        • University of California, San Diego
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
    • Colorado
      • Littleton, Colorado, United States
        • Recruiting
        • Colorado Neurological Institute
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States
      • New Haven, Connecticut, United States
        • Recruiting
        • Institutue for Neurodegenerative Disorders
        • Contact:
    • Florida
      • Miami, Florida, United States
        • Recruiting
        • University of Miami School of Medicine
        • Contact:
      • Tampa, Florida, United States
        • Recruiting
        • University of South Florida
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States
        • Recruiting
        • Emory University
        • Contact:
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
        • Recruiting
        • Rush University Medical Center
        • Contact:
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
      • Wichita, Kansas, United States
        • Recruiting
        • Hereditary Neurological Disease Center
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40294
        • Recruiting
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States
        • Recruiting
        • Johns Hopkins University
        • Contact:
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States
        • Recruiting
        • Boston University School of Medicine
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Active, not recruiting
        • Hennepin County Medical Center
    • Missouri
      • St. Louis, Missouri, United States
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • New York
      • Albany, New York, United States
        • Recruiting
        • Albany Medical College
        • Contact:
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
        • Recruiting
        • Duke University Medical Center
        • Contact:
      • Winston Salem, North Carolina, United States
        • Recruiting
        • Wake Forest University Baptist Medical Center
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States
        • Recruiting
        • University of Cincinnati
        • Contact:
      • Cleveland, Ohio, United States
        • Recruiting
        • The Cleveland Clinic
        • Contact:
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
        • Recruiting
        • University of Pittsburgh
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States
        • Recruiting
        • University of Tennessee-Memphis
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States
        • Recruiting
        • Baylor College of Medicine
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Charlottesville, Virginia, United States
        • Recruiting
        • University of Virginia
        • Contact:
    • Washington
      • Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HP Therapeutics Foundation

Collaborators

Huntington Study Group

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COHORT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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