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OpenTrials
Completed

NCT Number: NCT03316404

Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DxTerity Diagnostics

Compton, California, 90220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

DxTerity Diagnostics

Industry

Registry information

Acronym: EMPOWER

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2017
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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