Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The EXPLORE MG Registry for Myasthenia Gravis

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.
 
ClinicalTrials.gov Identifier: NCT03792659
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.

Condition or disease Intervention/treatment
Myasthenia Gravis Other: Blood Sample Draw

Detailed Description:
This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 8 Years
Official Title: Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry
Actual Study Start Date : March 30, 2016
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Neurological Outpatients
Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.
Other: Blood Sample Draw
Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.




Primary Outcome Measures :
  1. The number of successful blood draws will be reported at the conclusion of the sample collection [ Time Frame: 8 years ]
    Successful Collection of Blood


Secondary Outcome Measures :
  1. The number of stool samples collected will be reported at the conclusion of the sample [ Time Frame: 8 years ]
    Count of Stool Samples


Biospecimen Retention:   Samples Without DNA
100 cc (less than 1/2 cup) of blood


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.
Criteria

Inclusion Criteria:

  • Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data.

Exclusion Criteria:

  • Failure to meet the Inclusion Criteria.

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): NCT03792659


Contacts
Layout table for location contacts
Contact: Bailey Munro Sheldoon, PhD 203-737-7095 bailey.munrosheldon@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Bailey Munro Sheldon, PhD    203-737-7095    bailey.munrosheldon@yale.edu   
Principal Investigator: Richard Nowak, MD, MS         
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Richard Nowak, MD, MS Assistant Professor, Yale University
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03792659    
Other Study ID Numbers: 1602017284
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases