NCT07571525Not yet recruiting
Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis
Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis: An Observational Prospective Translational Cohort Study
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 14 Sept 2029
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Myasthenia gravis
- NCT number
- NCT07571525
What you commit to
- Study type: Observational
- Planned participants: 40
- From 15 Sept 2026 to the primary completion date, 14 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Inability to provide informed consent
- Pregnancy or breastfeeding
Who the study is looking for
- 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
- Participants must also meet the criteria for at least one of the following study groups:
- Cohort 1: Thymoma with MG-related antibodies
- Histologically or radiologically confirmed thymoma
- Presence of at least one pathogenic MG-related antibody (AChR)
- Presence or absence of clinically manifest myasthenia gravis
- Cohort 2: Other thymic abnormalities with MG-related antibodies
- Imaging or histological evidence of non-thymomatous thymic pathology (e.g., thymic hyperplasia)
- Presence of at least one pathogenic MG-related antibody (AChR)
- Presence or absence of clinically manifest myasthenia gravis
- Cohort 3: Thymoma without MG-related antibodies
- Histologically or radiologically confirmed thymoma
- Negative for pathogenic MG-related antibodies (AChR)
- No clinical diagnosis or symptoms suggestive of myasthenia gravis
- Cohort 4: Myasthenia gravis without thymic abnormalities
- Established clinical diagnosis of myasthenia gravis with consistent clinical features, supported by at least one of the following:
- Seropositivity for MG-related antibodies (AChR, MuSK, or LRP4), or
- Abnormal neuromuscular transmission demonstrated by SFEMG or RNS, or
- Improvement of MG signs with treatment such as oral acetylcholinesterase inhibitors, plasma exchange, IVIg, or corticosteroids
- Absence of thymic abnormalities on CT or MRI
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.