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Investigation of Biomarkers in Susac Syndrome

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT01273792
Collaborator
(none)
30
Enrollment
1
Location
139
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult. The aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of Susac syndrome

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. Because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed.

    The aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and healthy subjects as controls are investigated.

    Furthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of Susac syndrome.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigation of Relevant Biomarkers in Patients With Susac Syndrome
    Study Start Date :
    May 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Susac syndrome
    Matched healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. disease specific patterns of pathology on cranial MRI []

      one-time cranial MRI

    2. disease specific patterns of pathology in optical coherence tomography []

      one time optical coherence tomography

    3. serological biomarkers [not defined, cross-sectional analysis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • adult male and female patients with definite Susac syndrome or matching healthy control subjects

    • ability to provide informed consent

    Exclusion Criteria:
    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Jan M Dörr, MD, NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jan-Markus Dörr, PD Dr. med., Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01273792
    Other Study ID Numbers:
    • Biomarkers Susac Syndrome
    First Posted:
    Jan 11, 2011
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Susac Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jul 29, 2021