The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

NCT01623076 | Active Not Recruiting

• 1 other identifier: STU 022012-084
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine the biologic causes of inflammation in patients with Transverse Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Conditions

Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Transverse Myelitis; Optic Neuritis

Keywords

Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Transverse Myelitis; Optic Neuritis; Biorepository

Outcome Measures

Primary Outcomes (1)

• Measure change in standard clinical assessments over time

  Standard clinical assessments include: relapse information, level of disability based on EDSS score, high and low contract visual acuity, ambulation index, optical coherence tomography, and MRI, and neurologic/physical exam

  Every study visit

Secondary Outcomes (3)

• Measure change in cognition measures over time

  Every study visit

• Measure change in self-reported quality of life surveys

  Every study visit

• B cell population changes

  Up to 5 years

Study Arms (4)

Neuromyelitis Optica Spectrum Disorder

Patients diagnosed with NMOSD based on revised diagnostic criteria. Seronegative, anti-AQP4 seropositive and ant-MOG seropositive patients will be included

Transverse Myelitis and Optic Neuritis

Patients who have had one demyelinating event, not diagnosed with multiple sclerosis and whom are considered at risk for NMO or NMOSD.

Healthy Controls

patients without a history of CNS inflammation

Neuromyelitis Optica

patients diagnosed with NMO

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously diagnosed with Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis will be recruited to take part in a longitudinal study of their disease.

You may qualify if:

• Age 6 years or greater
• Male or Female
• Patient or Parent (in the case of a minor) able to give informed consent
• For patients 10 to 17, patient able to assent
• Patient diagnosed with NMO, NMOSD, TM or ON

You may not qualify if:

• Unable to maintain scheduled visits
• Patient has known HIV or hepatitis C infection

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Links

• Transverse Myelitis Association

Biospecimen

Retention: SAMPLES WITH DNA

Patients will donate serum, plasma, DNA, RNA and white blood cells.

MeSH Terms

Conditions

Neuromyelitis Optica; Myelitis, Transverse; Optic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Central Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases

Study Officials

• Benjamin M Greenberg, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuromyelitis Optica and Transverse Myelitis Program

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: June 1, 2012
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)