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Trial record 2 of 184 for:    "huntington disease"

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

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ClinicalTrials.gov Identifier: NCT01554033
Recruitment Status : Unknown
Verified March 2012 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2012
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
European Huntington's Disease Network
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date March 11, 2012
First Posted Date March 14, 2012
Last Update Posted Date March 19, 2012
Study Start Date May 2009
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01554033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN)
Official Title Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN).
Brief 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. 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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum-60ml urine-60ml Formation study of Lymphoblast and diagnosis of a Huntington gene
Sampling Method Probability Sample
Study Population primary care clinic
Condition Huntington Disease
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March¬†13,¬†2012)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01554033
Other Study ID Numbers H-0902-023-271
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators European Huntington's Disease Network
Investigators
Study Chair: Kim Manho, MD, PhD Department of Neurology, Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2012