Enroll-HD is a global observational study and clinical research platform which provides a clinical research infrastructure to facilitate development of HD therapeutics. The Enroll-HD study collects biosamples and clinical data to support the design and conduct of clinical trials. The study also aims to better understand the pathobiological mechanisms and phenotypic spectrum in HD and promote the development of evidence-based guidelines to inform clinical practice and improve health outcomes.
Clinical data in Enroll-HD
Clinical data collected in Enroll-HD include a broad spectrum of demographic, medical history and clinical assessment data. Please refer to the Data Dictionary or the Annotated CRF:Enroll-HD for a full list of variables, and to the assessments chart below for a study overview. There is no fee associated with clinical data access.
Enroll-HD clinical data are shared with the research community via:
- Periodic Datasets (PDS)
- Specified Datasets (SPS)
- My Site Data (only data collected by your Enroll-HD site)
Periodic datasets are prepared from the Enroll-HD study database every 1-2 years and include a large majority of the variables collected. Each Enroll-HD PDS goes through stringent QC and de-identification procedures prior to release. During this process certain variables are transformed, aggregated, or suppressed (excluded) in each PDS release to minimize the risk of participant identification.
Access to non-transformed, non-aggregated, or suppressed data may be obtained via SPS request, subject to review and approval by the Enroll-HD Scientific Review Committee (SRC); the SRC will review your request and weigh the scientific potential of the proposed project against the increased risk for participant identification and recommend whether the requested dataset should be prepared and released. Estimated timelines for SPS delivery are provided on the Access Data & Biosamples page.
The Data Dictionary denotes which variables are available in the PDS, which ones are available via SPS request, and which ones are never released.
My Site Data enables Enroll-HD PIs to request access to just the Enroll-HD data collected at their own clinical site for research projects, but prior approval must obtained from CHDI. My Site Data requests require that a SPS request is submitted for review by the Enroll-HD operational team.
Enroll-HD data collected, including the assessments administered, are summarized below. Core assessments are required at each annual visit, whereas extended assessments are only administered at sites that have the capacity and interest. Optional assessments are only administered if participants specifically consent.
|Results of local HD genetic testing (if applicable)||X|
|Participant HD category as determined by Investigator||X|
|HD Clinical Characteristics (HDCC)||X|
|Reportable event monitoring||X|
|UHDRS ‘99 Motor||X|
|UHDRS ‘99 Diagnostic Confidence Index||X|
|UHDRS ‘99 Total Functional Capacity||X|
|UHDRS ‘99 Function Assessment Scale||X|
|UHDRS ‘99 Independence Scale||X|
|Problem Behaviors Assessment-Short (PBA-s)||X|
|Hospital Anxiety/ Depression Rating Scale (HADS)||X|
|Snaith Irritability Scale (SIS)||X|
|Columbia Suicide Severity Rating Scale (CSSR)||X|
|Symbol Digit Modality Test||X|
|Stroop Word Reading||X|
|Categorical Verbal Fluency||X|
|Stroop Color Naming||X|
|Trail Making A & B||X|
|Letter Verbal Fluency||X|
|Mini Mental State Examination (MMSE)||X|
|Timed Up and Go (TUG)||X|
|30-second Chair Stand Test||X|
|Short Form Health Survey-12 (SF-12)||X|
|Companion Quality of Life Questionnaire||X|
|Client Services Receipt Inventory (CSRI)||X|
|Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)||X|
|Research genotyping (conducted at first visit for either new participants or those from previous studies who don’t have a research genotype)||X|
|Biospecimens for biobanking||X|
Biosamples in Enroll-HD
Most Enroll-HD participants consent to donate biosamples, which are classed as either renewable or non-renewable.
- Renewable: lymphoblastoid cell lines; DNA from lymphoblastoid cell lines
- Non-renewable: DNA from whole blood; PBMCs; EDTA plasma (not fasted)
Renewable biosamples can be replenished indefinitely and are ordinarily released without review.
Non-renewable biosamples are only available in finite amounts so requests for these are reviewed by the SRC before release.
Enroll-HD biosample overview and prices
Available Enroll-HD biosamples, aliquot sizes and sample prices are summarized below. Academic use is offered at a 20% discount. Shipping and handling costs are not included and will depend on shipping requirements (e.g., frozen) and distance – estimated costs will be given for each request.
|Sample type||Unit||Biosample type||Price per sample in € (Industry)||Price per sample in € (Academia)|
|Lymphoblastoid cell line||1*106 cells||Renewable||46||38|
|DNA from cell line||5 µg||Renewable||73||61|
|DNA from whole blood||5 µg||Non-renewable||99||83|
|EDTA plasma||250-300 µl||Non-renewable||24||20|
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