PROUD is a multicentre prospective study, using clinical factors in combination with additional tests with the aim to clarify more about the aetiology and pathogenesis of MS.
ID
Source
Brief title
Condition
- Vision disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is there an association between clinical, immunological and infection
parameters and progression to MS after a first event of demyelination.
Secondary outcome
- Are current diagnostic McDonald criteria also valid for clinically isolated
syndromes in typical neurological practice (non-academic) settings?
- Are certain single nucleotide polymorphisms (SNP*s) over represented in the
subgroup progressing to clinically definite MS or associated with
benign/aggressive courses?
Background summary
Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system
and is a main cause of disability among young adults in the Western world.
After a first clinical episode of (suspected) central nervous system
demyelination, it is still hard to predict the clinical course. There has been
a considerable amount of research in different fields with the aim to
understand more about the cause of MS but also to predict the course of MS from
the onset. Available studies have largely focussed on conventional markers,
Magnetic Resonance Imaging (MRI) and cerebrospinal fluid. However, the
influence of clinical parameters, such as fatigue and smoking, on developing MS
after a first event has not been explored yet.
Study objective
PROUD is a multicentre prospective study, using clinical factors in combination
with additional tests with the aim to clarify more about the aetiology and
pathogenesis of MS.
Study design
Patients, who fulfil the inclusion criteria, will receive by their neurologist
oral and written information about the PROUD study. After the patient has
decided to participate and has signed the informed consent forms, extra blood
samples will be stored at the time of routine vena puncture. If a lumbar
puncture is performed, extra cerebrospinal fluid will also be stored. Clinical
and laboratory data will be filled on CRF's (Case Report Forms). CRF's, a copy
of the MRI and the extra samples will be sent to the researchers in Erasmus MC.
Also yearly policlinic visits and interim visits will be reported to the
researchers in Erasmus MC.
Feces sample will be collected once. The diet questionnaire will be filled in
once and send together with the faeces sample to the Erasmus MC.
Controls will be asked to hand in feces sample and fill in one questionnaire.
Patients and controls will be asked to fill in a food diary for 3 days prior to
feces collection.
Study burden and risks
PROUD study is an observational study, trying to answer research questions by
patient interview and clinical follow-up. Additional storage of patient samples
is performed in parallel with samples for routine diagnostic purpose.
In case of fatigue two extra questionnaires (Fatigue Severity Score (FSS) and
Hospital Anxiety and Depression Scale (HADS)) will be completed at the first
visit and yearly control visits. The extra burden for the patient at the
baseline and yearly visits will be about 6-7 minutes for FSS and HADS.
A feces sample will be collected once at baseline. Patients and controls will
fill in a diet questionnaire once and a food diary for 3 days and send this
together with the faeces sample to the Erasmus MC. Feces collection and the
diet questionnaire together will take 10 minutes. The food diary will take 8
minutes per day (for 3 days).
Controls will hand in a feces sample once. They will fill in a diet
questionnaire once and a food diary for 3 days and send this together with the
faeces sample to the Erasmus MC. Feces collection and the diet questionnaire
together will take 10 minutes. The food diary will take 8 minutes per day (for
3 days).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
For patients:
1. Patients with a Clinically Isolated Syndrome (CIS) suggestive of central nervous system demyelination involving the optic nerve, brainstem or spinal cord.
2. Age > 18 years en < 50 years
3. Visit to the neurologist and clinical, blood, (CSF) and MRI examination within 6 months from the onset.;For controls for microbiome research:
1. Preferably from the same household as the patient
Exclusion criteria
For patients and controls:
Sever co-morbidity like AIDS, cancer or other severe diseases with shortening life expectance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12306.078.06 |