Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
|First Received Date ICMJE||April 6, 2012|
|Last Updated Date||April 30, 2014|
|Start Date ICMJE||July 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01574053 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort|
|Official Title ICMJE||Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort|
Enroll-HD is a longitudinal, observational, multinational study that will integrate two existing Huntington's Disease (HD) registries, REGISTRY in Europe and COHORT in North America and Australia, while also expanding to include sites in Latin America and Asia. With no end date and annual assessments, the goal of Enroll-HD is to build a large and rich database of longitudinal clinical information and biospecimens. This database will serve as a basis for future studies aimed at developing tools and biomarkers for progression and prognosis, identifying clinically relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies.
The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With over 200 sites in roughly 30 countries, Enroll HD will be the largest database available for HD researchers.
|Study Type ICMJE||Observational [Patient Registry]|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||1 Year|
|Biospecimen||Retention: Samples With DNA
|Sampling Method||Non-Probability Sample|
Patients with HD and their family members will be recruited from specialty clinics (Human Genetics, Neurology, Psychiatry) that advise and treat people affected by HD. In addition, in some areas community clinics and neurologists who see HD patients will recruit participants for this study.Participants may also receive information about the study through a website, clinical practices, support groups, advocacy newsletters, etc. and place a direct request to be considered for participation in the study. Community controls will be identified, using advertisements, flyers and newsletters, by study site staff with the support of the Enroll-HD operational staff.
|Condition ICMJE||Huntington's Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||15000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
These two major categories can be further subdivided into six different subgroups of eligible individuals:
Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.
Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States, Argentina, Australia, Canada, Chile, Germany, Italy, New Zealand, Poland, United Kingdom|
|NCT Number ICMJE||NCT01574053|
|Other Study ID Numbers ICMJE||Enroll -HD|
|Has Data Monitoring Committee||Yes|
|Responsible Party||CHDI Foundation, Inc.|
|Study Sponsor ICMJE||CHDI Foundation, Inc.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||CHDI Foundation, Inc.|
|Verification Date||April 2014|
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