Clinical trial NCT02855476: HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Official title: HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Huntington's Disease
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: CHDI Foundation, Inc.
First posted: 2016-08-04
Enrollment: 2500
Sex: ALL
Minimum age (years): 11
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants across 8 clinical cohorts will be enrolled at multiple sites up to an estimated minimum of 2500 participants or until the study is terminated by either the Funding Source or Sponsor

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.

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

Primary outcomes:
measure: The primary objective of this study is:
timeFrame: years N/A
Secondary outcomes:
measure: The secondary objectives of this study are:
timeFrame: years N/A
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Cenexel
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Vancouver
country: Canada
facility: University of British Columbia, The Centre for Huntingtons Disease
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Centre for Movement Disorders
state: Ontario
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bordeaux
country: France
facility: Le Centre Hospitalier Universitaire de Bordeaux
city: Ulm
country: Germany
facility: University Hospital Ulm
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Dresden University
state: Saxony
city: Bochum
country: Germany
facility: St Josef And Elisabeth Hospital
city: Erlangen
country: Germany
facility: University Hospital of Erlangen
city: Münster
country: Germany
facility: George Huntington Institute
city: Taufkirchen
country: Germany
facility: Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
city: Milan
country: Italy
facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
city: Rome
country: Italy
facility: Lega Italiana Ricera Huntington
city: Grafton
country: New Zealand
facility: The University of Auckland
state: Auckland
city: Christchurch
country: New Zealand
facility: NZ Brain Research Institute
state: Canterbury
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
city: Bilbao
country: Spain
facility: Cruces University Hospital
state: Biscay
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Madrid
country: Spain
facility: Ramón y Cajal Universitary Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
state: Devon
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility
state: Scotland
city: Birmingham
country: United Kingdom
facility: Birmingham Huntingtons Disease Clinic
state: West Midlands
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Kirkcaldy
country: United Kingdom
facility: Fife Health Board - Whyteman's Brae Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital Trust
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Of London
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
affiliation: University College, London
name: Edward J Wild, MA, MB BChir, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References: