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Clinical Trials/NCT02994121
NCT02994121
Recruiting
Not Applicable

Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

University of Pittsburgh1 site in 1 country7,500 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Pittsburgh
Enrollment
7500
Locations
1
Primary Endpoint
Investigate the predictors of the variations in disease trajectory and treatment response
Status
Recruiting
Last Updated
4 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
January 1, 2047
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zongqi Xia

MD, PhD

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for MS patients include:
  • Age 7 years or older
  • 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)
  • 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:
  • Age 7 years or older
  • 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)
  • No known personal history of multiple sclerosis or related disorders
  • No other chronic diseases
  • Family members, unrelated household controls, or controls from the general population could be eligible

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Investigate the predictors of the variations in disease trajectory and treatment response

Time Frame: 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.

Establish a prospective cohort of well-characterized MS patients and controls

Time Frame: within 30 years

For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).

Study Sites (1)

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