Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis (CIS-COHORT)
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Purpose
A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.
| Condition |
|---|
|
Multiple Sclerosis, MS Clinically Isolated Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT) |
- time (in days) until relapse during the observation period of four years [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood samples (serum and plasma, with DNA), urine, saliva, CSF (if routine lumbar puncture was performed, no additional lumbar punctures for the study)
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| CIS or early relapsing-remitting MS |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.
Inclusion Criteria:
- age > 18 years
- signed informed consent
- clinically isolated syndrome within the last 6 months
- diagnosis of multiple sclerosis within the last two years
Exclusion Criteria:
- eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy)
- secondary progressive multiple sclerosis
- pregnancy
- contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- alcohol or drug abuse
Contacts and Locations| Contact: Friedemann Paul, Prof. | 0049 30 450 ext 539040 | friedemann.paul@charite.de |
| Contact: Klemens Ruprecht, Dr. | 0049 30 450 ext 560374 | klemens.ruprecht@charite.de |
| Germany | |
| NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Friedemann Paul, Prof. 0049 30 450 ext 539040 friedemann.paul@charite.de | |
| Sub-Investigator: Seija Lehnardt, Prof. | |
| Department of Neurology, Charité - Universitätsmedizin Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Klemens Ruprecht, Dr. 0049 30 450 ext 560 374 klemens.ruprecht@charite.de | |
| Principal Investigator: | Friedemann Paul, Prof. | Charite - Universitätsmedizin Berlin |
| Principal Investigator: | Klemens Ruprecht, Dr. | Charite University, Berlin, Germany |
| Principal Investigator: | Judith Bellmann-Strobl, Dr. | Charite University, Berlin, Germany |
More Information
Additional Information:
No publications provided
| Responsible Party: | Friedemann Paul, MD; Klemens Ruprecht, MD; Judith Bellmann-Strobl, MD, Charité - Universiätsmedizin Berlin |
| ClinicalTrials.gov Identifier: | NCT01371071 History of Changes |
| Other Study ID Numbers: | EK1/2011 |
| Study First Received: | June 8, 2011 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Charite University, Berlin, Germany:
|
Clinically isolated syndrome (CIS) Multiple sclerosis (MS) Immunomodulatory therapy |
Prognostic markers MRI OCT |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013