Huntington DiseaseNCT01554033
Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN)
An observational study of Huntington Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers. It is an open-ended study which will include as many eligible participants as willing to participate. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- The following individuals may be eligible to participate
- Individuals, confirmed HD mutation carrier
- Manifest HD, without CAG testing
- HD family member at-risk, without CAG testing
- HD family member, non-HD mutation carrier
- REGISTRY-CONTROL participants: companion/individual without HD history
- REGISTRY-COMPANION (any of the above). Participants may be male or female and of any age. All participants must be able to provide consent for themselves, have a parent/guardian who can provide parental permission, or have an authorised legal representative who can provide consent.
Who cannot join
- Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology, Seoul National University Hospital
Seoul, Seoul, 110744
Kim Manho, MD, PhD, +822-2072-2193, kimmanho@snu.ac.kr
About this study
Official title: Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN).
REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers. It is an open-ended study which will include as many eligible participants as willing to participate. The goal of the project is to collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers regardless of whether they display clinical symptoms and signs of the disease and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to:
- obtain natural history data on a wide spectrum of HD mutation carriers and individuals who are part of an HD family
- relate phenotypical characteristics
- with genetic factors ('genetic modifiers')
- with data derived from the study of body fluids (blood, urine - 'wet biomarker') and
- imaging data ('dry biomarker')
- expedite identification and recruitment of participants for clinical trials
- develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care.
- plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).
Read the detailed description
To collect prospective data on the phenotypical characteristics of HD mutation carriers regardless of whether they display clinical symptoms and signs of HD and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to;
- obtain natural history data on a wide spectrum of HD patients, HD mutation carriers and individuals who are part of an HD family
- relate phenotypical characteristics with
- genetic factors ('genetic modifiers'),
- data derived from the study of body fluids (blood, urine - 'wet biomarker') and
- imaging data ('dry biomarker')
- expedite identification and recruitment of participants for clinical trials
- develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD, and which may also be potential outcome measures for use in future clinical trials and clinical care.
- plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).
To achieve these objectives, participants are asked to donate biosamples (blood and urine) for studies to identify genetic modifiers of HD and to establish and validate biological markers tracking the progressive course of HD; in this context a family history is requested as well in order to understand the relationships of clinical data sets and biosamples from related donors. In addition, non-mutation carrying family members of participants are asked to consider donating biosamples to serve as controls.
- Conditions
- Huntington Disease
- Keywords
- European Huntington's Disease Network, Huntington patients in KOREA
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Huntington's disease patients | Huntington's disease patients and his(/her) family | |
| age-sex matched control | age-sex matched control about huntington patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Huntington's Disease Network
- Responsible party
- Sponsor
- Investigators
- Kim Manho, MD, PhD, Study chair, Department of Neurology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554033
- Sponsor's protocol ID
- H-0902-023-271
- Status last verified
- Mar 2012
- First submitted
- 11 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN).
- ClinicalTrials.gov ID
- NCT01554033
- Acronym / sponsor ID
- H-0902-023-271
- Conditions
- Huntington Disease
- Keywords
- European Huntington's Disease Network, Huntington patients in KOREA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- European Huntington's Disease Network
- Study start
- May 2009
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers. It is an open-ended study which will include as many eligible participants as willing to participate. The goal of the project is to collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers regardless of whether they display clinical symptoms and signs of the disease and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to:
- obtain natural history data on a wide spectrum of HD mutation carriers and individuals who are part of an HD family
- relate phenotypical characteristics
- with genetic factors ('genetic modifiers')
- with data derived from the study of body fluids (blood, urine - 'wet biomarker') and
- imaging data ('dry biomarker')
- expedite identification and recruitment of participants for clinical trials
- develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care.
- plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).
Detailed description
To collect prospective data on the phenotypical characteristics of HD mutation carriers regardless of whether they display clinical symptoms and signs of HD and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to;
- obtain natural history data on a wide spectrum of HD patients, HD mutation carriers and individuals who are part of an HD family
- relate phenotypical characteristics with
- genetic factors ('genetic modifiers'),
- data derived from the study of body fluids (blood, urine - 'wet biomarker') and
- imaging data ('dry biomarker')
- expedite identification and recruitment of participants for clinical trials
- develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD, and which may also be potential outcome measures for use in future clinical trials and clinical care.
- plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).
To achieve these objectives, participants are asked to donate biosamples (blood and urine) for studies to identify genetic modifiers of HD and to establish and validate biological markers tracking the progressive course of HD; in this context a family history is requested as well in order to understand the relationships of clinical data sets and biosamples from related donors. In addition, non-mutation carrying family members of participants are asked to consider donating biosamples to serve as controls.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huntington's disease patients | – | –Huntington's disease patients and his(/her) family |
| age-sex matched control | – | –age-sex matched control about huntington patients |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 listed)
- The following individuals may be eligible to participate
- Individuals, confirmed HD mutation carrier
- Manifest HD, without CAG testing
- HD family member at-risk, without CAG testing
- HD family member, non-HD mutation carrier
Key exclusion criteria (1 listed)
- Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Manho, MD, PhD study chair
Department of Neurology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Manho, MD, PhD (+822-2072-2193, kimmanho@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.