Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: blood sample

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)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Christian Enzinger, Prof.; Phone Number: +43/316/ 385-82180; Email: chris.enzinger@medunigraz.at
• Study Contact Backup: Name: Michael Khalil, MD; Phone Number: +43/316/385-30313; Email: michael.khalil@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Medical University of Graz
      • Contact: Christian Enzinger, Prof.; Phone Number: +43/316/ 385-82180; Email: chris.enzinger@medunigraz.at
      • Contact: Michael Khalil, MD; Phone Number: +43/316/385-30313; Email: michael.khalil@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Conversion from CIS to MS defined by MRI and clinical criteria	a maximum of 4 years
Time of transition to progressive form of MS	Time of transition to progressive form of MS	a maximum of 4 years
Neuropsychological progression (decrease in SDMT performance)	Neuropsychological progression (decrease in SDMT performance)	a maximum of 4 years
Increase in morphological damage (lesion load, atrophy)	Increase in morphological damage (lesion load, atrophy)	a maximum of 4 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Christian Enzinger, Prof, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MRI; cognition; biomarker; progression
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MarkMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No