Clinical Data and Biosamples
Data sharing is essential to developing therapeutics for Huntington’s disease. Enroll-HD is a clinical research platform intended to accelerate progress towards the development of therapeutics that will benefit HD-affected individuals. Towards that goal, the longitudinal, code-protected clinical data and renewable and non-renewable biosamples collected from Enroll-HD participants are made available to any interested researcher working at a recognized research institution through a straightforward qualification process. The wide availability of these resources aims to energize HD research and encourage a broad variety of ideas and projects.
Researchers requesting data and biosamples will be asked to sign the respective agreements governing access and use of these resources which include requirements to uphold privacy.
Periodic datasets (typically every 6 months) are time-stamped cuts of the Enroll-HD clinical dataset. Enroll-HD clinical data consists of longitudinal data from participants’ annual visits from countries around the world. Each participant has completed a baseline visit and a set of general forms. At least one on-site monitoring visit has been completed for each participant in the dataset. For participants who return, there is additional follow-up data. Refer to the Data Dictionary and Annotated CRF:Enroll-HD for a list of variables collected in the study.
Provided that participants have consented to biobanking, their blood samples collected at baseline and each follow-up visit are used to derive lymphoblastoid cell lines and DNA from this renewable source (called renewable DNA); these are available in 1×106 cell and 5 ug [microgram] aliquots, respectively. Researchers requesting these biosamples must complete the Biosample Request Form (Enroll-HD or HDClarity), download and sign the Biosamples Use Agreement and pay the fee associated with the biosamples (fees listed below).
PBMCs samples are also available from participants who have consented to biobanking. Researchers requesting these non-renewable samples are required to complete a Biosample Request Form (Enroll-HD or HDClarity), download and sign the Biosamples Use Agreement and provide the scientific rationale for their project, which will be reviewed by the Scientific Publication Review Committee for approval; and pay the fee associate with the biosamples (fees listed below).
Enroll-HD Biosamples Storage and Processing Cost Table
The table below provides the types of available biosamples and the aliquot size. The table below sets forth the type of biosamples available and the storage and processing cost per such biosample. Academic use is offered at a 20% discount.
Amount per sample
Amount per sample
|PBMCs||Vial (1mL)||€ TBD||€ TBD|
|Lymphoblastoid cell (LBC) line||Vial (1×106 cells)||€ 38.00||€ 46.00|
|DNA From LBCs||Vial (5 µg)||€ 61.00||€ 73.00|
|DNA From LBCs in 96-well format
per well in 96 well plate format
|Single well2 (5 µg)||€ 64.00||€ 77.00|
1 Prices do not include shipping and handling costs.
2 Price quoted is for a single well on a 96-well plate.
3 Please submit this form to inquire PBMCs amount per biosample.
Enroll-HD Assessments and Coverage Chart
The tables below summarize the Enroll-HD data and biosamples available. The first table is the list of clinical assessments performed in the study; the second table is a coverage chart that describes the type and quantity of the data and biosamples.
These charts provide information exclusively about the current periodic dataset and Enroll-HD study protocol. Information about previous datasets and protocols can be found with their associated periodic dataset.
This table lists the assessments performed as part of the Enroll-HD Study. The Core Assessments are required and performed at every visit. The Extended Assessments are optional and performed by sites based on their interest and capacity. The Optional Assessments require additional participant consent and are only performed if consent is granted.
|Written informed consent/ parental permission/assent||x|
|Creation of the unique HDID||x|
|Review of Inclusion/Exclusion Criteria||x|
|Local diagnostic laboratory CAG report (if available)||x|
|Investigator and research genotyping determined classification of participant||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|
|Global Clinical Impression1||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 the first visit for all new participants to the study or for participants from previous studies for whom a research genotype is not available)||x|
|Biospecimens for biobanking||x|
1The GCI is not being collected in this version of Enroll-HD
The table below illustrates the number of entries in the current periodic dataset by region and participant category for the Enroll-HD study only.
|Region||HD Category||Baseline Visit||FU Visit 2||FU Visit 3||FU Visit 4||FU Visit 5||FU Visit 6||FU Visit 7|
|Europe||pre-manifest/premotor – manifest HD||2036||1153||720||338||79||5||<5|
|Latin America||pre-manifest/premotor – manifest HD||7||5||<5|
|Northern America||pre-manifest/premotor – manifest HD||1284||749||510||294||161||69||7|
|Australasia||pre-manifest/premotor – manifest HD||212||148||110||57||25||<5|