Clinical trial NCT01623076: The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
Official title: Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - the Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Transverse Myelitis
Optic Neuritis
Keywords: Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Transverse Myelitis
Optic Neuritis
Biorepository
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Transverse Myelitis (TM), optic neuritis (ON), related conditions and healthy controls. 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.

Patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Measure change in standard clinical assessments over time
timeFrame: Every study visit
Secondary outcomes:
measure: Measure change in cognition measures over time
timeFrame: Every study visit
measure: Measure change in self-reported quality of life surveys
timeFrame: Every study visit
measure: B cell population changes
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Benjamin M Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: