HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
- Conditions
- Huntington's Disease
- Registration Number
- NCT02855476
- Lead Sponsor
- University College, London
- Brief Summary
HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.
- Detailed Description
This is a longitudinal open-ended observational study. Participants will attend two annual study visits, an Annual Screening Visit followed by an Annual Sampling Visit, and may also attend an optional visit during the first year of enrollment, an Optional Repeat Sampling Visit.
During the Annual Screening Visit, medical history, and clinical and phenotypic data will be obtained. Participants who meet the eligibility requirements of the study and are willing to continue in the study, will return for an Annual Sampling Visit. During that visit, biosamples will be collected following a fast of at least 6 hours, or overnight: blood will be obtained via venipuncture and CSF will be obtained via lumbar puncture. Some participants may be invited to return for an Optional Repeat Sampling Visit approximately 4-8 weeks after the Annual Sampling Visit during their first year of enrolment.
The annual visits are at regular intervals after the first Annual Screening Visit (i.e. at 1, 2, 3 years and so on) ± 2 months. Participants will be encouraged to complete all annual visits; however, they are under no obligation to take part and will be able to skip annual visit without being discontinued from the study. Participants who do not come for an Annual Sampling Visit for three consecutive years will be discontinued from the study, but they may enrol again at a later date, if they so consent. Participants who have already completed HDClarity Sampling Visits under earlier versions of this protocol may also participate in the longitudinal study if they meet the eligibility criteria.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- Age (18-75 years controls, early/late premanifest HD and incomplete penetrance HD, 21-75 years early/moderate/advanced manifest HD, ≥11 years juvenile HD)
- Enroll HD participant
- Capable of consenting or have a legal representative (parent/guardian for juveniles)
- Capable of complying with study procedures
- All participants other than family and community controls must have had a genetic test for HD
- Drug trial within 30 days of any sampling visit
- Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)
- Antiplatelet or anticoagulant therapy within 14 days
- Significant comorbidity
- Needle phobia, headache, spinal surgery / deformity
- Clotting or bruising disorder
- Screening blood test abnormalities >10% outside normal range
- Drug / alcohol abuse
- Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential
- Predictable non compliance or unwillingness
- Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is: years N/A To generate a high quality CSF sample collection for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD.
- Secondary Outcome Measures
Name Time Method The secondary objectives of this study are: years N/A To generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.
To collect phenotypic and clinical data for each participant.
Trial Locations
- Locations (39)
Cenexel
🇺🇸Englewood, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
John Hopkins University
🇺🇸Baltimore, Maryland, United States
University of British Columbia, The Centre for Huntingtons Disease
🇨🇦Vancouver, British Columbia, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Centre for Movement Disorders
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Le Centre Hospitalier Universitaire de Bordeaux
🇫🇷Bordeaux, France
University Hospital Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Dresden University
🇩🇪Dresden, Saxony, Germany
St Josef And Elisabeth Hospital
🇩🇪Bochum, Germany
University Hospital of Erlangen
🇩🇪Erlangen, Germany
George Huntington Institute
🇩🇪Münster, Germany
Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
🇩🇪Taufkirchen, Germany
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
🇮🇹Milan, Italy
Lega Italiana Ricera Huntington
🇮🇹Rome, Italy
The University of Auckland
🇳🇿Grafton, Auckland, New Zealand
NZ Brain Research Institute
🇳🇿Christchurch, Canterbury, New Zealand
Institute of Psychiatry and Neurology
🇵🇱Warsaw, Poland
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Cruces University Hospital
🇪🇸Bilbao, Biscay, Spain
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, Devon, United Kingdom
North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
The Walton Centre NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Ramón y Cajal Universitary Hospital
🇪🇸Madrid, Spain
Glasgow Clinical Research Facility
🇬🇧Glasgow, Scotland, United Kingdom
Birmingham Huntingtons Disease Clinic
🇬🇧Birmingham, West Midlands, United Kingdom
Fife Health Board - Whyteman's Brae Hospital
🇬🇧Kirkcaldy, United Kingdom
St George's University Of London
🇬🇧London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Cardiff University
🇬🇧Cardiff, United Kingdom
Leeds Teaching Hospital Trust
🇬🇧Leeds, United Kingdom