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Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

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ClinicalTrials.gov Identifier: NCT01574053
Recruitment Status : Unknown
Verified June 2015 by CHDI Foundation, Inc..
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Enroll-HD is a longitudinal, observational, multinational study that will integrate two existing Huntington's Disease (HD) registries, REGISTRY in Europe and COHORT in North America and Australia, while also expanding to include sites in Latin America and Asia. With no end date and annual assessments, the goal of Enroll-HD is to build a large and rich database of longitudinal clinical information and biospecimens. This database will serve as a basis for future studies aimed at developing tools and biomarkers for progression and prognosis, identifying clinically relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies.

Condition or disease
Huntington's Disease

Detailed Description:
The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With over 200 sites in roughly 30 countries, Enroll HD will be the largest database available for HD researchers.

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Study Start Date : July 2012


Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with HD and their family members will be recruited from specialty clinics (Human Genetics, Neurology, Psychiatry) that advise and treat people affected by HD. In addition, in some areas community clinics and neurologists who see HD patients will recruit participants for this study.Participants may also receive information about the study through a website, clinical practices, support groups, advocacy newsletters, etc. and place a direct request to be considered for participation in the study. Community controls will be identified, using advertisements, flyers and newsletters, by study site staff with the support of the Enroll-HD operational staff.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Individuals who do not meet inclusion criteria,
  • 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 disease, Multiple Sclerosis, etc.).

Participants under 18 may be eligible to participate (if they have juvenile-onset HD).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574053


Contacts
Contact: James Moyer EnrollHD@quintiles.com

  Show 131 Study Locations
Sponsors and Collaborators
CHDI Foundation, Inc.
Investigators
Principal Investigator: Bernhard G Landwehrmeyer, MD, PhD University of Ulm
Study Director: Joseph Giuliano CHDI Management Inc.
More Information

Responsible Party: CHDI Foundation, Inc.
ClinicalTrials.gov Identifier: NCT01574053     History of Changes
Other Study ID Numbers: Enroll -HD
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by CHDI Foundation, Inc.:
Huntington's Disease
Huntington Disease
Juvenile Huntington's Disease
Registry
Cohort
CHDI

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
Neurocognitive Disorders
Mental Disorders