HDClarity
HDClarity
Study Details
as of October 10, 2024
- Study: HDClarity
- Sponsor: University College London
- Type: Non-Therapeutic
- Duration: 2017 - Present
- Status: Active, Recruiting
- No. Participants (target): Up to 2,500
- No. Participants (current): 1,057 (includes HD-CSF participants; N=80), October 10, 2024
- No. Sites: 36
- Imaging Data: No
- Biosamples: Yes
- Data from Biosamples: Yes
Get involved!
Read more about the HDClarity study and find out how to participate.
About HDClarity
HDClarity is a longitudinal open-ended observational study. Participants attend two annual study visits; an annual screening visit followed by an annual sampling visit and may also attend a further optional sampling visit during the first year of enrollment. 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. The study is open to Enroll-HD participants aged 18-75 years who have a known HD genetic status or are control participants. Juvenile HD participants age ≥ 11 years can also take part.
During the annual screening visit, clinical and phenotypic data will be obtained. Participants who meet the eligibility requirements are willing to continue in the study, will return for the annual sampling visit during which ≤20ml CSF and approximately 50ml blood will be collected.
The primary objective is to collect a high-quality CSF sample for longitudinal 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.
Clinical datasets
Available clinical datasets associated with this study are displayed below. These are made available free of charge. The data elements and assessments captured in the HDClarity study are also illustrated below.
Available via the Enroll-HD platform. Visit the Access page for more information.
Biosamples
Available biosamples associated with this study are displayed below, alongside aliquot sizes and biosample prices. There is a 20% discount on biosamples for academic use. Shipping and handling fees are provided separately on request, and depend on shipping type and distance.
Participant biosamples are not sold for profit. Biosample fees (i) are applied to partially offset the costs of collecting and storing the requested biosamples, and (ii) give people requesting biosamples a sense of the actual “cost” of their experiments.
Available via the Enroll-HD platform. Visit the Access page for more information.
Data from biosamples
Available biosample datasets (e.g., methylation data) associated with biosamples collected from this study are displayed below.
Available via the Enroll-HD platform. Visit the Access page for more information.
HDClarity
Data elements and assessments
The data elements and assessments captured in the HDClarity study are displayed below. Entries are reflective of HDClarity protocol V4.1.
General
- Sociodemographic data
- Weight (at discretion of investigator)
Medical
- HD medical history*
- Pharmacotherapies*
- Non-pharmacotherapies*
- Nutritional supplements*
- Neurological examination
- Physical exam
- Vital signs (BP, pulse, body temp)
- Pregnancy test
- AEs (with respect to study procedures)
Motor
- UHDRS® '99 Motor (TMS)
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Function
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Behavior
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Cognition
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Genotyping
- Research CAG genotyping data are not generated per HDClarity protocol, but these data are available for all HDClarity participants from their participation in Enroll-HD. All HD participants must have a local CAG report to participate in HDClarity.
Quality of life
- Assessment data may be available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Health economics
- Assessment data may be available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Family history
- Pedigree charting data may be available from Enroll-HD, as gathered under the Enroll-HD study protocol.
Biosample
- CSF
- Venous blood (serum, plasma)
Imaging
- Imaging data are not collected in HDClarity. Imaging data are available for those HDClarity participants enrolled in ImageClarity.
*Update respective prior to Enroll-HD visit
General
- Sociodemographic data
- Weight (at discretion of investigator)
Medical
- HD medical history*
- Pharmacotherapies*
- Non-pharmacotherapies*
- Nutritional supplements*
- Neurological examination
- Physical exam
- Vital signs (BP, pulse, body temp)
- Pregnancy test
- AEs (with respect to study procedures)
Motor
- UHDRS® '99 Motor (TMS)
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Function
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Behavior
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Cognition
- Additional assessment data are available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Genotyping
- Research CAG genotyping data are not generated per HDClarity protocol, but these data are available for all HDClarity participants from their participation in Enroll-HD. All HD participants must have a local CAG report to participate in HDClarity.
Quality of life
- Assessment data may be available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Health economics
- Assessment data may be available from prior Enroll-HD visit (conducted within 3 months of HDClarity Annual Screening Visit).
- Please refer to Enroll-HD Data Elements and Assessments for details.
Family history
- Pedigree charting data may be available from Enroll-HD, as gathered under the Enroll-HD study protocol.
Biosample
- CSF
- Venous blood (serum, plasma)
Imaging
- Imaging data are not collected in HDClarity. Imaging data are available for those HDClarity participants enrolled in ImageClarity.
*Update respective prior to Enroll-HD visit
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