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.
Key facts
- Who runs it
- CHDI Foundation, Inc.
- Where
- Gdansk, Katowice, Krakow, Poznan, and Warsaw, PolandSee the 6 sitesAlso in 19 other countries, 177 sites
- Trial code
- Registry title
- Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
- Status
- Recruiting
- People taking part
- 35,000 people, planned
- Started
- Jul 2012
- Expected to end
- Jan 2062
- Type of study
- Observational
- Record updated
- 28 February 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study is looking for people with the Huntington's disease gene change, and also for relatives and other people without it who serve as controls.
- Age
- 18 Years and older; people under 18 can join if they have juvenile-onset Huntington's disease.
- Sex
- All sexes can join.
- Disease stage
- People who carry the HD gene change, with or without clear signs of Huntington's disease (manifest or pre-manifest). Some groups do not carry the gene change.
- Biomarker or test result
- Carrying the HD gene expansion mutation, or not carrying it (controls); relatives may have an unknown gene status.
Main reasons for not taking part
- People who do not meet the inclusion criteria
- People with choreic movement disorders and a negative test for the HD gene mutation
- Community controls with a major central nervous system disorder, such as stroke, Parkinson's disease or multiple sclerosis
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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,
Where in Poland
Also in 19 other countries, 177 sites
- Copernicus Podmiotem Leczniczym sp. z o.o.Gdansk, PolandContact: Ewa NarożańskaTaking people
- Krakowska Akademia Neurologii Sp. z o.oKatowice, PolandContact: Agnieszka PrymusTaking people
- Krakow - Krakowska Akademia NeurologiiKrakow, PolandContact: Marta PinkoszTaking people
- Solumed Centrum MedycznePoznan, PolandContact: Noopur ModiNo longer taking part
- Institute of Psychiatry and Neurology, WarsawWarsaw, PolandContact: Karolina Ziora-JakutowiczTaking people
- Medical University of WarsawWarsaw, PolandContact: Noopur ModiNo longer taking part
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
- Plain-language title
- Follows people with Huntington's disease over time through yearly checkupsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 February 2024