Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

Completed

• Conditions: MS; Multiple Sclerosis

• Registration Number: NCT03316404
• Lead Sponsor: DxTerity Diagnostics

Brief Summary

To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Detailed Description

Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.

Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.

In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-11-07
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1168

Inclusion Criteria

• Male and female patients age 18 or older
• Have a permanent address in the United States for the duration of the study
• Have an email address and access to the internet for the duration of the study
• Able to provide informed consent
• Self-reported diagnosis of MS

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)	2 years	Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) to develop a blood test to characterize MS status by analyzing gene expression from blood samples.

Trial Locations

Locations (1)

DxTerity Diagnostics; 🇺🇸 Compton, California, United States