Version: 1.0.0 | Published: 14 Feb 2025 | Updated: 379 days ago
Documentation
Associated Media:
Description:
A repository of biosamples from DECISIve trial participants (optional participation). Purpose: to enable biomarker discovery studies
to be conducted after full enrolment into the trial. Focusing on biomarkers that predict who will go on to develop MS, but may also include how that person’s MS will progress, how their MS will respond to treatment or to measure how well treatments are working at an early stage.
The samples were collected at the lumbar puncture visits from individuals who have presented with typical clinically isolated syndrome and are undergoing diagnostic evaluation of MS. The biorepository samples include:
1. One sample of cerebrospinal fluid (of up to five millilitres). Unhaemolysed CSF was collected in polypropylene tubes, centrifuged, separated and the supernatant frozen in separate aliquots in polypropylene secondary tubes, preferably within one hour of the LP. The CSF was frozen and transported on dry ice. CSF has been kept frozen at -80 oC.
2. One sample of blood (of up to 50 millilitres), drawn at the same time as the clinical blood test. This was collected in vacutainers with clotting activator and subsequently allowed to clot for at least 30 minutes at room temperature. Separation of serum was achieved by centrifugation. Samples were aliquoted in polypropylene screw cap vials and frozen at -80 oC.
The PIs are responsible for the samples’ storage and authorising access to the samples. The samples will be analysed within national or international centres of expertise.
Other data available:
year of birth
gender
ethnicity
smoking status
presenting symptom(s)
date of first clinical symptom
details of any subsequent suspected clinical events
mode of presentation to MS team e.g. emergency admission, referral from ophthalmology/GP
date of study enrolment
baseline investigation results from blood tests and radiological investigation performed prior to
enrolment.
T2* MRI scan performed as a research MRI scan. The following two scans were acquired using a pre-defined protocol. 1) High resolution 3D T2* and 2) 3D FLAIR. The investigations took place as soon as possible after enrolment into the study with a limit on the time between the lumbar puncture and research MRI of eight weeks.
Coverage
Spatial:
Wales, UK
Typical Age Range:
18-65
Follow Up:
1 - 10 Years
Pathway:
Patients recruited whilst having diagnostic work up for MS, after presenting
with typical onset CIS. Samples are collected during routine clinical procedures
(LP and blood tests). MRI research scan data also available. Follow up
questionnaires completed every 6 months over 18 month period. Routine clinical
care results in one of three outcomes: Formal diagnosis with MS and ongoing
management under the MS team Formal diagnosis with an alternative condition
and discharge from the MS team A diagnosis of clinically isolated syndrome and
a period of observation under the MS team to see if MS develops.
Provenance
Origin
Purposes:
- Research cohort
- Trial
Sources:
Other
Collection Situations:
- Cohort, study, trial
- Secondary care - Outpatients
Temporal
Accrual Periodicity:
Other
Start Date:
01 March 2020
Time Lag:
Variable
Accessibility
Access
Access Service:
in progress
Access Request Cost:
An indicative cost will be provided to applicants upon application. Charges will
be based on workload associated with the application. Discussions surrounding
costs to access material should be initiated prior to funding applications being
made.
Delivery Lead Time:
Variable
Jurisdictions:
UK
Data Controller:
Cardiff University
Data Processor:
Cardiff University
Usage
Data Use Limitations:
Research-specific restrictions
Data Use Requirements:
- Project-specific restrictions
- Collaboration required
Resource Creators:
tbc
Format and Standards
Vocabulary Encoding Schemes:
- LOCAL
- SNOMED CT
Conforms To:
LOCAL
Languages:
en
Formats:
text
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Events
No. of CSF sample aliquots available (300ul)
301
CSF aliquot
14 February 2025
Events
No. of participants that provided CSF samples
25
CSF donor
14 February 2025
Events
No. of SERUM aliquots available (300ul)
93
SERUM aliquot
14 February 2025
Events
No. of participants that provided SERUM samples
15
Serum donor
14 February 2025
Persons
No. of DECISIve trial participants that have opted into Cardiff biorepository
25
Participants of DECISIve trial
14 February 2025