Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
The goal of this observational study is to investigate the clinical, immunological, and neuromuscular features associated with the development and progression of myasthenia gravis (MG) in adult patients with thymic abnormalities and/or MG-related antibodies, including individuals with or without clinically manifest disease.
The main questions it aims to answer are:
* Whether integrated clinical, serological, and histopathological profiles are associated with the presence of MG and can predict disease onset or progression * Wheter systemic immune markers are associated with disease activity, progression, and neuromuscular junction alterations
Participants will:
* Undergo clinical, neurological, and neurophysiological assessments at baseline and during follow-up * Provide blood samples for serological and immunological analyses * Provide thymic tissue and residual intercostal muscle samples (when undergoing clinically indicated thymectomy) for research analyses * Attend follow-up visits at 6, 12, and 18 months * Record daily symptoms using an electronic patient-reported outcome tool (for participants with MG)
Eligibility criteria
Qualifiers
Age ≥18 years at the time of informed consent
Ability to provide written informed consent and comply with study procedures
Availability of a serum sample for testing MG-related antibodies
Availability of chest imaging (CT and/or MRI) to classify thymic status
Disqualifiers
Inability to provide informed consent
Other neuromuscular diseases that could interfere with interpretation of clinical or neurophysiological findings
Severe uncontrolled systemic illness that, in the investigator's judgment, may limit participation or confound study outcomes
Any medical or psychiatric condition, or history of substance abuse, that may compromise adherence to study procedures
Trial design
Treatments tested in this trial
- Not listed
Trial groups
40 Participants
are grouped into 4 trial groupsSponsors and collaborators
Source ClinicalTrials.gov