PROMOTE: Prospective Investigation of Multiple Sclerosis in the Three Rivers Region
Study Details
Study Description
Brief Summary
In this longitudinal prospective natural history study of multiple sclerosis (MS), the overarching goal is to understand the factors that influence individual variation in disease trajectory and treatment response and pave the way for realizing precision medicine in MS. Because MS is a chronic neurological disorder, this observational cohort study will span a 30-year time frame.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes, Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis, Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor Inventory, and the COVID19 Response Surveys.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| People with Multiple Sclerosis or Related Disorders Individuals must be 7 years or older, diagnosed with multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease |
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| People without Multiple Sclerosis or Related Disorders Control participants must be 7 years or older, have no known personal history of multiple sclerosis or related disorders, no other chronic disease, and can be a family member, unrelated household control, or control from the general population. |
Outcome Measures
Primary Outcome Measures
- Establish a prospective cohort of well-characterized MS patients and controls [within 30 years]
For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).
- Investigate the predictors of the variations in disease trajectory and treatment response [within 30 years]
Understanding the factors that influence disease trajectory and treatment response will pave the way to realize precision medicine in delivering individualized MS care.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Inclusion criteria for MS patients include:
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willing and able to give consent
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age 7 years or older
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diagnosis of multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease
- For healthy controls:
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Age 7 years or older
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Willing and able to provide consent (for >=18 years) or assent with permission from at least one of the child's parents (for <18 years)
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No known personal history of multiple sclerosis or related disorders
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No other chronic diseases
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Family members, unrelated household controls, or controls from the general population could be eligible
There is no exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15260 |
Sponsors and Collaborators
- University of Pittsburgh
Investigators
- Principal Investigator: Zongqi Xia, MD, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO16050143/STUDY19080007