Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT02994121

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT02994121

Start date

Dec, 2016

Status verified date

Dec, 2025

Completion date

Jan, 2047

Anticipated

Primary completion date

Jan, 2047

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Inclusion criteria for MS patients include:

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. 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 Design

Enrollment

7500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Establish a prospective cohort of well-characterized MS patients and controls [ Time Frame: within 30 years ]
  • Investigate the predictors of the variations in disease trajectory and treatment response [ Time Frame: within 30 years ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Zongqi Xia, MD, PhD

412-383-5377

More Information

Sponsor

University of Pittsburgh

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-12-29.