Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

NCT02994121 | Recruiting DMC

• 1 other identifier: STUDY19080007
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with multiple sclerosis and related disorders and controls

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine, saliva, and cerebrospinal fluid collection

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zongqi Xia, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongqi Xia, MD, PhD

CONTACT

412-383-5377; msstudy2@pitt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): January 1, 2047
• Study Completion (Estimated): January 1, 2047
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (1)