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The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

This study is currently recruiting participants.
Verified June 2017 by Benjamin Greenberg, University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623076
First Posted: June 19, 2012
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Greenberg, University of Texas Southwestern Medical Center
  Purpose
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.

Condition
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Transverse Myelitis Optic Neuritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Resource links provided by NLM:


Further study details as provided by Benjamin Greenberg, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Measure change in standard clinical assessments over time [ Time Frame: Every study visit ]
    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


Secondary Outcome Measures:
  • Measure change in cognition measures over time [ Time Frame: Every study visit ]
    Cognition measures include the SDMT, JLO, and PASAT

  • Measure change in self-reported quality of life surveys [ Time Frame: Every study visit ]
    Surveys include MSNQ, MSQOL-54, QIDS, BDI-II, FSS, ESS, MFIS, BPI, and Neuro-QoL

  • B cell population changes [ Time Frame: Up to 5 years ]
    Measure B cell subtypes and changes over time


Biospecimen Retention:   Samples With DNA
Patients will donate serum, plasma, DNA, RNA and white blood cells.

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623076


Contacts
Contact: Giselle Cherry, BA 214-645-7949 Giselle.chery@utsouthwestern.edu
Contact: Samuel Hughes, BS 214-645-7977 Samuel.Hughes@utsouthwestern.edu

Locations
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Benjamin M Greenberg, MD, MHS         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Benjamin M Greenberg, MD University of Texas Southwestern Medical Center
  More Information

Additional Information:
Responsible Party: Benjamin Greenberg, Director, Neuromyelitis Optica and Transverse Myelitis Program, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01623076     History of Changes
Other Study ID Numbers: STU-022012-084
First Submitted: June 15, 2012
First Posted: June 19, 2012
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data can be shared with IRB approved researchers upon request and approval from PI

Keywords provided by Benjamin Greenberg, University of Texas Southwestern Medical Center:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Transverse Myelitis
Optic Neuritis
Biorepository

Additional relevant MeSH terms:
Myelitis
Myelitis, Transverse
Disease
Neuritis
Optic Neuritis
Neuromyelitis Optica
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases