Follows people with Huntington's disease over time through yearly checkups
Observes adults with Huntington's disease through yearly checkups, collecting health information and samples.
Plain-language title generated from the registry record
Registry title: Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Key facts
- Where
- Melbourne, Parkville, Perth, and Westmead, AustraliaSee the 4 sites
Where in Australia
- Monash UniversityMelbourne, AustraliaTaking people
- University of Melbourne, Royal Melbourne HospitalParkville, AustraliaTaking people
- The Neurosciences Unit - North Metropolitan HospitalPerth, AustraliaTaking people
- Westmead HospitalWestmead, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CHDI Foundation, Inc.
- Trial code
- NCT01574053
- Record updated
- 28 February 2024
- Original description
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 30,000 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.Read full original descriptionShow less
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
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 30,000 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.
Inclusion: 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: 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.
Exclusion: 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); Individuals who do not meet inclusion criteria,.