Biorepository for DECISIve - DiagnosE using the Central veIn SIgn. A prospective diagnostic superiority study comparing T2* MRI and lumbar puncture in patients presenting with possible Multiple Sclerosis. Purpose: biomarker discovery studies. Focus on biomarkers that predict how MS develops, progresses , and responds to treatment. Samples were collected at the lumbar puncture visits for diagnostic work up :

1. cerebrospinal fluid
2. serum

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.