Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Multiple Sclerosis Clinical Trial

— PROMOTE  

Official title:

Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02994121
• Other study ID #: STUDY19080007
• Status: Recruiting
• Start date: December 2016
• Est. completion date: January 2047

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Zongqi Xia, MD, PhD
• Phone: 412-383-5377
• Email: msstudy2[@]pitt.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: January 2047
• Est. primary completion date: January 2047
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a prospective cohort of well-characterized MS patients and controls	For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).	within 30 years
Primary	Investigate the predictors of the variations in disease trajectory and treatment response	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