Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

NCT04892134 | Unknown

• 1 other identifier: MarkMS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

biomarker; progression; MRI; cognition

Outcome Measures

Primary Outcomes (1)

• Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease

  EDSS score

  a maximum of 4 years

Secondary Outcomes (5)

• 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

  a maximum of 4 years

• Time of transition to progressive form of MS

  a maximum of 4 years

• Neuropsychological progression (decrease in SDMT performance)

  a maximum of 4 years

• Increase in morphological damage (lesion load, atrophy)

  a maximum of 4 years

Interventions

blood sample OTHER

40-50 ml of blood is taken

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, peripheral blood mononuclear cells, DNA, urine

MeSH Terms

Conditions

Multiple Sclerosis; Disease Progression

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christian Enzinger, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Enzinger, Prof.

CONTACT

+43/316/ 385-82180; chris.enzinger@medunigraz.at

Michael Khalil, MD

CONTACT

+43/316/385-30313; michael.khalil@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 19, 2021
• Study Start: October 3, 2019
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

AU (1)