Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis

NCT07853378 | Not Yet Recruiting

• 1 other identifier: Post-Thymectomy MG Relapse
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months post-thymectomy

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Myasthenia Gravis; Thymoma; Recurrence; Neuromuscular Junction Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Diseases; Immune System Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Thymus Neoplasms; Thoracic Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09