Trial record 12 of 101 for:    "huntington disease"

Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
European Huntington's Disease Network
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01554033
First received: March 11, 2012
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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).

Condition
Huntington Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN).

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Biospecimen Retention:   Samples With DNA

serum-60ml urine-60ml Formation study of Lymphoblast and diagnosis of a Huntington gene


Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Huntington's disease patients
Huntington's disease patients and his(/her) family
age-sex matched control
age-sex matched control about huntington patients

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.

  Eligibility

Ages Eligible for Study:   1 Year to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554033

Contacts
Contact: Kim Manho, MD, PhD +822-2072-2193 kimmanho@snu.ac.kr

Locations
Korea, Republic of
Department of Neurology, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Kim Manho, MD, PhD    +822-2072-2193    kimmanho@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
European Huntington's Disease Network
Investigators
Study Chair: Kim Manho, MD, PhD Department of Neurology, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01554033     History of Changes
Other Study ID Numbers: H-0902-023-271
Study First Received: March 11, 2012
Last Updated: March 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
European Huntington's Disease Network
Huntington patients in KOREA

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014