Cooperative Huntington's Observational Research Trial

• ClinicalTrials.gov Identifier: NCT00313495
• Recruitment Status: Recruiting
• First Posted: April 12, 2006
• Last Update Posted: March 7, 2011
• Sponsor: HP Therapeutics Foundation
• Collaborator: Huntington Study Group
• Information provided by: HP Therapeutics Foundation

Tracking Information

• 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: Complete list of historical versions of study NCT00313495 on ClinicalTrials.gov Archive Site
• 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

• 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.

• Condition: Huntington Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.
• Huntington Study Group COHORT Investigators, Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16. Erratum in: PLoS One. 2012;7(8). doi: 10.1371/annotation/25881bc7-922d-4472-9efd-f0896b1a3499.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 10, 2006): 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:

• (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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Huntington Study Group; 800-487-7671

• Listed Location Countries: Australia, Canada, United States

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

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

• PRS Account: HP Therapeutics Foundation
• Verification Date: March 2011