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

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ClinicalTrials.gov Identifier: NCT02994121
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Zongqi Xia, University of Pittsburgh

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
Multiple Sclerosis

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, and Social Network Questionnaire.

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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Investigation of Multiple Sclerosis in the Three Rivers Region
Study Start Date : December 2016
Estimated Primary Completion Date : January 2047
Estimated Study Completion Date : January 2047

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Establish a prospective cohort of well-characterized MS patients and controls [ Time Frame: within 30 years ]
  2. 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.


Biospecimen Retention:   Samples With DNA
Blood, stool, urine, saliva, and cerebrospinal fluid collection


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People with multiple sclerosis and related disorders and controls
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994121


Contacts
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Contact: Zongqi Xia, MD, PhD 412-383-5377 msstudy2@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Zongqi Xia, MD, PhD    412-383-5377      
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Zongqi Xia, MD, PhD University of Pittsburgh

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Responsible Party: Zongqi Xia, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02994121     History of Changes
Other Study ID Numbers: PRO16050143
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases