Investigation of Biomarkers in Susac Syndrome | NCT01273792

Studies
Investigation of Biomarkers in Susac Syndrome

NCT01273792

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jul 29, 2021Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Susac Syndrome

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Jul 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan-Markus Dörr, PD Dr. med., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease specific patterns of pathology on cranial MRI	one-time cranial MRI
disease specific patterns of pathology in optical coherence tomography	one time optical coherence tomography
serological biomarkers		not defined, cross-sectional analysis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with Susac syndrome (male/female; healthy control subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan M Dörr, MD	Contact	+49 30 450	660162	jan-markus.doerr@charite.de

Overall Officials

Name	Affiliation	Role
Jan M Dörr, MD	NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin	Recruiting	Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19953118	Background	Dorr J, Radbruch H, Bock M, Wuerfel J, Bruggemann A, Wandinger KP, Zeise D, Pfueller CF, Zipp F, Paul F. Encephalopathy, visual disturbance and hearing loss-recognizing the symptoms of Susac syndrome. Nat Rev Neurol. 2009 Dec;5(12):683-8. doi: 10.1038/nrneurol.2009.176.

Label	Type	Description	Intervention Names
Patients with Susac syndrome
Matched healthy controls

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases