Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

  • STATUS
    Recruiting
  • End date
    Jan 20, 2062
  • participants needed
    20000
  • sponsor
    CHDI Foundation, Inc.
Updated on 20 May 2021
chorea

Summary

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Description

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 158 active clinical sites in 19 countries, Enroll-HD is now the largest HD database available and is accessible to any interested researcher - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Details
Condition Dementia, Huntington's Chorea, Huntington's Disease
Clinical Study IdentifierNCT01574053
SponsorCHDI Foundation, Inc.
Last Modified on20 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation
Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation
These two major categories can be further subdivided into six different
subgroups of eligible individuals
Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD
Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD
Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status
Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation
Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers)
Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies
Participant status will be captured in the study database using 2 variables
) 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

Exclusion Criteria

Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation
For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.)
Participants under 18 may be eligible to participate (if they have juvenile-
onset HD)
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