HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Huntington's Disease. Basic parameters: 11 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Germany, Italy +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- The primary objective of this study is: [Time frame: years N/A]
Secondary outcome measures (1)
- The secondary objectives of this study are: [Time frame: years N/A]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 13 centers
- Royal Devon & Exeter NHS Foundation Trust — Exeter
- Glasgow Clinical Research Facility — Glasgow
- Birmingham Huntingtons Disease Clinic — Birmingham
- North Bristol NHS Trust — Bristol
- Cambridge University Hospitals NHS Foundation Trust — Cambridge
- Cardiff University — Cardiff
- Fife Health Board - Whyteman's Brae Hospital — Kirkcaldy
- Leeds Teaching Hospital Trust — Leeds
- … and 5 more centers
United States · 6 centers
- Cenexel — Englewood
- Georgetown University — Washington D.C.
- John Hopkins University — Baltimore
- Wake Forest University — Winston-Salem
- Vanderbilt University Medical Center — Nashville
- University of Texas Health Science Center — Houston
Germany · 6 centers
- University Hospital Ulm — Ulm
- Dresden University — Dresden
- St Josef And Elisabeth Hospital — Bochum
- University Hospital of Erlangen — Erlangen
- George Huntington Institute — Münster
- Kbo-Isar-Amper-Klinikum Taufkirchen (Vils) — Taufkirchen
Canada · 4 centers
- University of British Columbia, The Centre for Huntingtons Disease — Vancouver
- The Ottawa Hospital — Ottawa
- North York General Hospital — Toronto
- Centre for Movement Disorders — Toronto
Spain · 3 centers
- Cruces University Hospital — Bilbao
- Hospital de Sant Pau — Barcelona
- Ramón y Cajal Universitary Hospital — Madrid
France · 2 centers
- Centre Hospitalier Universitaire d'Angers — Angers
- Le Centre Hospitalier Universitaire de Bordeaux — Bordeaux
Italy · 2 centers
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta — Milan
- Lega Italiana Ricera Huntington — Rome
New Zealand · 2 centers
- The University of Auckland — Grafton
- NZ Brain Research Institute — Christchurch
Poland · 1 center
- Institute of Psychiatry and Neurology — Warsaw
Portugal · 1 center
- Gulbenkian Institute of Molecular Medicine — Lisbon
Identifiers
NCT: NCT02855476 · 15/0519