Evaluation of Clinical, Morphologic and Biochemical Marke... | NCT04892134

Studies
Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

NCT04892134

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Oct 19, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

blood sample

Countries

Austria

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

Oct 2023

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

Oct 3, 2019Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

May 4, 2021

First Submission Date that Met QC Criteria

May 18, 2021

First Posted Date

May 19, 2021Actual

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

Oct 18, 2023

Last Update Posted Date

Oct 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

Detailed Description

The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Other	40-50 ml of blood is taken

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease	EDSS score	a maximum of 4 years

Secondary Outcomes

Measure	Description	Time Frame
Prediction of clinical relapses	Prediction of clinical relapses	a maximum of 4 years
Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected or proven multiple sclerosis
The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria

Exclusion Criteria:

Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria with suspected or proven multiple sclerosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Enzinger, Prof.	Contact	+43/316/ 385-82180		chris.enzinger@medunigraz.at
Michael Khalil, MD	Contact	+43/316/385-30313		michael.khalil@medunigraz.at

Overall Officials

Name	Affiliation	Role
Christian Enzinger, Prof	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz	Recruiting	Graz	Styria	8010	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41797387	Derived	Hechenberger S, Broeders TAA, Bet MDA, Helmlinger B, Tinauer C, Ropele S, Heschl B, Wurth S, Damulina A, Khalil M, Schoonheim MM, Enzinger C, Pinter D. Time-Varying Brain Functional Reconfiguration Patterns Associated With Fatigue in Multiple Sclerosis. Hum Brain Mapp. 2026 Mar;47(4):e70480. doi: 10.1002/hbm.70480.

ID	Term
D009103	Multiple Sclerosis
D018450	Disease Progression

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis