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Investigation of Biomarkers in Susac Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01273792
Recruitment Status : Recruiting
First Posted : January 11, 2011
Last Update Posted : July 29, 2021
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany

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
Susac Syndrome

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.

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

Resource links provided by the National Library of Medicine

Patients with Susac syndrome
Matched healthy controls

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 [ Time Frame: not defined, cross-sectional analysis ]

Biospecimen Retention:   Samples Without DNA
Blood samples (serum, Blood cells)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with Susac syndrome (male/female; healthy control subjects

Inclusion Criteria:

  • adult male and female patients with definite Susac syndrome or matching healthy control subjects
  • ability to provide informed consent

Exclusion Criteria:

  • pregnancy

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 identifier (NCT number): NCT01273792

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Contact: Jan M Dörr, MD +49 30 450 ext 660162

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NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin Recruiting
Berlin, Germany, 10117
Contact: Jan M Dörr, MD    +49 30 450 ext 660162   
Principal Investigator: Jan M Dörr, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Jan M Dörr, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
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Responsible Party: Jan-Markus Dörr, PD Dr. med., Charite University, Berlin, Germany Identifier: NCT01273792    
Other Study ID Numbers: Biomarkers Susac Syndrome
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Susac Syndrome
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Retinal Artery Occlusion
Retinal Diseases
Eye Diseases
Vision Disorders
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Eye Manifestations