RECRUITING

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Quick Facts

Study Start:2017-01
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02855476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Enroll HD participant
  3. * Capable of consenting or have a legal representative (parent/guardian for juveniles)
  4. * Capable of complying with study procedures
  5. * All participants other than family and community controls must have had a genetic test for HD
  1. * Drug trial within 30 days of any sampling visit
  2. * Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)
  3. * Antiplatelet or anticoagulant therapy within 14 days
  4. * Significant comorbidity
  5. * Needle phobia, headache, spinal surgery / deformity
  6. * Clotting or bruising disorder
  7. * Screening blood test abnormalities \>10% outside normal range
  8. * Drug / alcohol abuse
  9. * Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential
  10. * Predictable non compliance or unwillingness
  11. * Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days

Contacts and Locations

Study Contact

Katarzyna Schubert, PhD
CONTACT
hdclarity-cc@enroll-hd.org
Gail Owen, PhD
CONTACT
+44 1273 640 688
g.owen@ucl.ac.uk

Principal Investigator

Edward J Wild, MA, MB BChir, MRCP, PhD
PRINCIPAL_INVESTIGATOR
University College, London

Study Locations (Sites)

Cenexel
Englewood, Colorado
United States
Georgetown University
Washington, District of Columbia, 20057
United States
John Hopkins University
Baltimore, Maryland, 21287
United States
Wake Forest University
Winston-Salem, North Carolina, 27109
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States
University of Texas Health Science Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University College, London

  • Edward J Wild, MA, MB BChir, MRCP, PhD, PRINCIPAL_INVESTIGATOR, University College, London

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2017-01
Study Completion Date2025-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Huntington's Disease