Prospective Investigation of Multiple Sclerosis in the Three Rivers Region (PROMOTE)

January 3, 2024 updated by: Zongqi Xia, University of Pittsburgh
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • Zongqi Xia, MD, PhD
          • Phone Number: 412-383-5377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People with multiple sclerosis and related disorders and controls

Description

Inclusion Criteria:

  • Inclusion criteria for MS patients include:

    1. willing and able to give consent
    2. age 7 years or older
    3. 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:

    1. Age 7 years or older
    2. 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)
    3. No known personal history of multiple sclerosis or related disorders
    4. No other chronic diseases
    5. Family members, unrelated household controls, or controls from the general population could be eligible

There is no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within 30 years
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.
within 30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Zongqi Xia, MD, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Estimated)

January 1, 2047

Study Completion (Estimated)

January 1, 2047

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimated)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19080007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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