Cooperative Huntington's Observational Research Trial
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ClinicalTrials.gov Identifier: NCT00313495 |
Recruitment Status : Unknown
Verified March 2011 by HP Therapeutics Foundation.
Recruitment status was: Recruiting
First Posted : April 12, 2006
Last Update Posted : March 7, 2011
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Sponsor:
HP Therapeutics Foundation
Collaborator:
Huntington Study Group
Information provided by:
HP Therapeutics Foundation
Tracking Information | ||||
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First Submitted Date | April 10, 2006 | |||
First Posted Date | April 12, 2006 | |||
Last Update Posted Date | March 7, 2011 | |||
Study Start Date | February 2006 | |||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Cooperative Huntington's Observational Research Trial | |||
Official Title | Cooperative Huntington's Observational Research Trial | |||
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. | |||
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 | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Blood, DNA and Urine
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Sampling Method | Non-Probability Sample | |||
Study Population |
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Condition | Huntington Disease | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
5000 | |||
Original Enrollment | Same as current | |||
Estimated Study Completion Date | December 2020 | |||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Australia, Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00313495 | |||
Other Study ID Numbers | COHORT | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Ira Shoulson, MD/Principal Investigator, University of Rochester | |||
Study Sponsor | HP Therapeutics Foundation | |||
Collaborators | Huntington Study Group | |||
Investigators |
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PRS Account | HP Therapeutics Foundation | |||
Verification Date | March 2011 |