NCT05077956

Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).

Detailed description

This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS). A total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels: * Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS) * Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT) * Group 3: RMS patients receiving DMT with breakthrough disease * Group 4: Non-MS controls (patients without inflammatory CNS disease) Participants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up. The expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.

Conditions

• Relapsing Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cerebrospinal and Blood Serum Semaphorin 4A Levels	Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Timeline

• Start date: 2021-10-19
• Primary completion: 2023-10-25
• Completion: 2023-10-25
• First posted: 2021-10-14
• Last updated: 2023-08-07

Locations

1 site across 1 country: United States