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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00313495
Registration number
NCT00313495
Ethics application status
Date submitted
10/04/2006
Date registered
12/04/2006
Date last updated
7/03/2011
Titles & IDs
Public title
Cooperative Huntington's Observational Research Trial
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Scientific title
Cooperative Huntington's Observational Research Trial
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Secondary ID [1]
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COHORT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Huntington Disease
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- (1) Anyone who does not fit the inclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2020
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital - Wentworthville
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The University of Melbourne - Kew
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Recruitment hospital [3]
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Graylands, Selby-Lemnos & Special Care Health Services - Perth
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- Wentworthville
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Recruitment postcode(s) [2]
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- Kew
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Recruitment postcode(s) [3]
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6910 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Funding & Sponsors
Primary sponsor type
Other
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Name
HP Therapeutics Foundation
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Huntington Study Group
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00313495
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ira Shoulson, MD
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Address
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University of Rochester/Huntington Study Group
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Contact person for public queries
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Huntington Study Group
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Address
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Phone
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800-487-7671
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00313495
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