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

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ClinicalTrials.gov Identifier: NCT01371071
Recruitment Status : Unknown
Verified June 2011 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Study Description
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Brief Summary:
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 or disease
Multiple Sclerosis, MS Clinically Isolated Syndrome

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
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)
Study Start Date : January 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
CIS or early relapsing-remitting MS


Outcome Measures
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Primary Outcome Measures :
  1. time (in days) until relapse during the observation period of four years [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI) [ Time Frame: 48 months ]
  2. 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 ]
  3. Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV) [ Time Frame: 48 months ]

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)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371071


Contacts
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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

Locations
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Germany
Department of Neurology, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Klemens Ruprecht, Dr.    0049 30 450 ext 560 374    klemens.ruprecht@charite.de   
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.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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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
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Additional Information:

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Responsible Party: Friedemann Paul, MD; Klemens Ruprecht, MD; Judith Bellmann-Strobl, MD, Charité - Universiätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01371071    
Other Study ID Numbers: EK1/2011
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011
Keywords provided by Charite University, Berlin, Germany:
Clinically isolated syndrome (CIS)
Multiple sclerosis (MS)
Immunomodulatory therapy
 Prognostic markers
MRI
OCT
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Syndrome
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases