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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HP Therapeutics Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Huntington Study Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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