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Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis (CIS-COHORT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01371071
First received: June 8, 2011
Last updated: June 9, 2011
Last verified: June 2011

June 8, 2011
June 9, 2011
January 2011
December 2017   (final data collection date for primary outcome measure)
time (in days) until relapse during the observation period of four years [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01371071 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis
Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples (serum and plasma, with DNA), urine, saliva, CSF (if routine lumbar puncture was performed, no additional lumbar punctures for the study)

Non-Probability Sample

Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.

  • Multiple Sclerosis, MS
  • Clinically Isolated Syndrome
Not Provided
CIS or early relapsing-remitting MS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT01371071
EK1/2011
No
Friedemann Paul, MD; Klemens Ruprecht, MD; Judith Bellmann-Strobl, MD, Charité - Universiätsmedizin Berlin
Charite University, Berlin, Germany
Not Provided
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
Charite University, Berlin, Germany
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP