Myasthenia GravisNCT07853378
Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis
An observational study of Myasthenia Gravis and Thymoma, run by Assiut University.
Trial summary
Myasthenia gravis is an autoimmune disorder affecting neuromuscular transmission, characterized by fluctuating muscle weakness and fatigue. Surgical removal of the thymus gland (thymectomy) is an established treatment to help achieve disease control in eligible patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Thymoma
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients diagnosed with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals and have documented clinical follow-up for at least six months post-surgery.
Who may be able to join
- Age 18 years or older at the time of thymectomy
- Definite autoimmune myasthenia gravis based on compatible clinical findings with supporting electrophysiological and/or serological evidence
- History of thymectomy
- Adequate preoperative medical records
- Documented postoperative assessment sufficient to determine six-month outcome, unless a qualifying relapse or death occurs earlier
Who cannot join
- Congenital myasthenic syndromes
- Insufficient or unreliable medical records
- Absence of reliable postoperative clinical assessment
- Thymectomy performed for an unrelated indication without documented myasthenia gravis
- Major comorbid neurological disease making myasthenia gravis activity assessment unreliable
About this study
Official title: Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis: An Observational Longitudinal Study
Myasthenia gravis is an autoimmune disorder affecting neuromuscular transmission, characterized by fluctuating muscle weakness and fatigue. Surgical removal of the thymus gland (thymectomy) is an established treatment to help achieve disease control in eligible patients. However, surgery does not guarantee permanent remission, and some individuals experience disease recurrence or clinical worsening.
The main objective of this observational study is to determine the incidence and clinical predictors of early relapse occurring within the first six months following thymectomy. The study evaluates adult patients with confirmed autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. Patient characteristics, antibody profiles, pre-surgical disease severity, and postoperative follow-up assessments at 1, 3, and 6 months will be analyzed to identify factors associated with early clinical relapse.
- Conditions
- Myasthenia Gravis, Thymoma
- Keywords
- Thymectomy, Relapse, Recurrence, Myasthenic Crisis, Quantitative Myasthenia Gravis Score, Neuromuscular Junction Diseases, Autoimmune Diseases
- Medical subject headings
- Myasthenia Gravis, Thymoma, Recurrence, Neuromuscular Junction Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-Thymectomy Myasthenia Gravis Patients | Adult patients aged 18 years or older with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. This cohort is evaluated for the incidence, clinical phenotype, and predictors of early clinical relapse occurring within six months post-thymectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Myasthenia Gravis Relapse
Clinically significant relapse is defined as an objective worsening of myasthenia gravis muscle weakness that requires treatment escalation (including increased corticosteroid dosing, addition of non-steroidal immunosuppressive agents, or initiation of rescue therapy with plasma exchange or intravenous immunoglobulin).
Measured: 6 months post-thymectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Ahmed Abd Elgaber Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853378
- Sponsor's protocol ID
- Post-Thymectomy MG Relapse
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis: An Observational Longitudinal Study
- ClinicalTrials.gov ID
- NCT07853378
- Acronym / sponsor ID
- Post-Thymectomy MG Relapse
- Conditions
- Myasthenia Gravis, Thymoma
- Keywords
- Thymectomy, Relapse, Recurrence, Myasthenic Crisis, Quantitative Myasthenia Gravis Score, Neuromuscular Junction Diseases, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myasthenia gravis is an autoimmune disorder affecting neuromuscular transmission, characterized by fluctuating muscle weakness and fatigue. Surgical removal of the thymus gland (thymectomy) is an established treatment to help achieve disease control in eligible patients. However, surgery does not guarantee permanent remission, and some individuals experience disease recurrence or clinical worsening.
The main objective of this observational study is to determine the incidence and clinical predictors of early relapse occurring within the first six months following thymectomy. The study evaluates adult patients with confirmed autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. Patient characteristics, antibody profiles, pre-surgical disease severity, and postoperative follow-up assessments at 1, 3, and 6 months will be analyzed to identify factors associated with early clinical relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Thymectomy Myasthenia Gravis Patients | – | –Adult patients aged 18 years or older with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. This cohort is evaluated for the incidence, clinical phenotype, and predictors of early clinical relapse occurring within six months post-thymectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals and have documented clinical follow-up for at least six months post-surgery.
Key inclusion criteria (5 listed)
- Age 18 years or older at the time of thymectomy
- Definite autoimmune myasthenia gravis based on compatible clinical findings with supporting electrophysiological and/or serological evidence
- History of thymectomy
- Adequate preoperative medical records
- Documented postoperative assessment sufficient to determine six-month outcome, unless a qualifying relapse or death occurs earlier
Key exclusion criteria (5 listed)
- Congenital myasthenic syndromes
- Insufficient or unreliable medical records
- Absence of reliable postoperative clinical assessment
- Thymectomy performed for an unrelated indication without documented myasthenia gravis
- Major comorbid neurological disease making myasthenia gravis activity assessment unreliable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Clinically Significant Myasthenia Gravis Relapse
Time frame: 6 months post-thymectomy
Clinically significant relapse is defined as an objective worsening of myasthenia gravis muscle weakness that requires treatment escalation (including increased corticosteroid dosing, addition of non-steroidal immunosuppressive agents, or initiation of rescue therapy with plasma exchange or intravenous immunoglobulin).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis and Thymoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant Myasthenia Gravis Relapse (time frame: 6 months post-thymectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.