To identify prognostic factors for disease course and severity, as soluble and cellular biomarkers, immunological, genetic, radiological and demographics factors.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the prognostic value of various factors, such as soluble and
cellular biomarkers, immunological, genetic, radiological and environmental
factors.
Secondary outcome
N/A
Background summary
Multiple sclerosis (MS) is an autoimmune disease, characterised by
inflammation, demyelination and neurodegeneration of the central nervous system
(CNS). In general, the disease presents itself with a Clinically Isolated
Syndrome (CIS), a first episode of suspected inflammatory demyelination. A part
of the CIS-patients can be diagnosed with MS because of specific findings in
the MRI of the brain or spinal cord and in the cerebrospinal fluid. With a
second episode of neurological deficit based on demyelination (relapse),
Clinically Definite MS (CDMS) can be diagnosed. However, a part of the patient
with a CIS stay monophasic. Besides that, within de group of patient with MS
great variability in disease course exists, both in frequency, location and
severity of relapses and in secondary progression. In recent decades, progress
has been made in the prognosis of patient after CIS in both biomarkers and in
demographic and clinical factors. Despit this progress, it stays difficult to
predict the outcome of patient with CIS and an (recent) diagnosis of MS.
Besides that, it remains unclear why these differences in disease course and
severity exist. In order to treat (with immunomodulatory treatment) and guide
patient in the best possible way, it is essential to identify potential factors
that (may) influence the disease course and severity.
Study objective
To identify prognostic factors for disease course and severity, as soluble and
cellular biomarkers, immunological, genetic, radiological and demographics
factors.
Study design
The PROUD study 2.0 is a prospective, longitudinal observational cohort study
of the course of disease after CIS in adulthood. It is a continuation of the
PROUD study initiated in 2006 (MEC-2006-188). Patients who meet the inclusion
criteria are approached by their neurologist. Verbal and written information
about the study will be given to the potential subject. After obtaining
informed consent, the standard annual check-ups as part of regular care will be
expanded with additional clinical tests. During regular blood and cerebrospinal
fluid (CSF) sampling additional material will be requested to be stored for the
study. If no regular blood or CSF sampling is required, the patient will be
asked to withdraw a sample as part of the study: this may be refused without
further consequences. Data of performed MRI scans will be saved. No additional
imaging is done for the study. Patients will be sent two to five digital
questionnaires annually. Patients, their clinical data and the collected
samples will receive a unique code under which the data will be stored. Data
collection will take place by eCRF in Castor. We aim for a long follow-up of at
least 5 years. At the end of the study we will re-evaluate whether an extension
of the study has additional scientific value. A control group of healthy
persons will also be created, in which blood will be taken once and a single
digital questionnaire will be administered. There will be no follow up in the
control group. The intended study is observational and designed to follow daily
clinical practice. It will therefore not interfere with the standard care
currently provided to CIS and MS patients. If patients participate from a
recruiting centre, they may be asked to come to Erasmus MC for research up to
once a year, in addition to the standard annual check-ups in their own
hospital.
Study burden and risks
This is an observational study with negligible risk to the patient. For the
collection of both clinical and radiological data, and for the collection of
blood and CSF samples, the visits and punctures that the patient already has to
undergo for regular care will be used. Questionnaires will be sent out annually
and, on an optional basis, blood and liquor samples will be requested once at
least five years later. These questionnaires and blood and CSF sampling are
outside the scope of regular care. If patients participate from a recruiting
centre, they may be asked to come to Erasmus MC, in addition to the standard
annual check-ups for treatment in their own hospital, no more than once a year.
There is no expected benefit for the individual patient for participation in
this study.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patient group:
1. Age >=18 years and <=65 years;
2. Perceived CIS: first episode of symptoms suggesting demyelination of the
central nervous system
3. Inclusion is possible within 6 months of onset of symptoms.
It does not matter whether the criteria for MS diagnosis are met at inclusion.
Or: participant of original PROUD study
Control group: healthy adults, such as family members and relatives of the CIS
patient at the neurology outpatient clinic.
1. Age >=18 years and <=65 years;
2. No history of chronic neurological disease or autoimmune disease
Exclusion criteria
1. Severe comorbidity with a life expectancy of 6 months or less at the time of
inclusion.
2. Alternative diagnosis as infection or systemic inflammatory disease as
etiology of demyelination.
Design
Recruitment
Medical products/devices used
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 | NL79673.078.21 |