Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
EMPOWER
1 other identifier
observational
1,168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2020
CompletedAugust 6, 2024
August 1, 2024
2.3 years
October 17, 2017
August 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)
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.
2 years
Study Arms (2)
Cohort 1
Cohort 1 of the study will collect blood samples from participants in various states of the disease. After qualification and informed consent, accepted participants will be sent a blood collection kit and will be asked to complete a study-related questionnaire.
Cohort 2
Cohort 2 may be conducted at selected clinical sites where MS treatment-naïve patients who are entering a new treatment paradigm will be sought. At the clinical site, patients will be qualified, consented, and a small amount (up to 1mL) of blood will be collected. Between approximately 1 week and 6 months of treatment on the new drug, the participant will be sent another blood collection kit for microsample collection and a brief questionnaire at home. A final sample will be collected between 3 and 6 months after the start of treatment. Within 6 months of initiating treatment, the site will be asked to provide information regarding the health and treatment status of the participant.
Eligibility Criteria
Participants diagnosed with Multiple Sclerosis (MS)
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DxTerity Diagnostics
Compton, California, 90220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
November 7, 2017
Primary Completion
February 24, 2020
Study Completion
February 25, 2020
Last Updated
August 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share