- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102192
The Role of the Thymus in Myasthenia Gravis
Study Overview
Status
Conditions
Detailed Description
On one hand we want to perform a detailed analysis of the T-cells generated in thymomas in terms of their functional capacity and their specificity. We will analyse blood and thymoma tissue of patients with myasthenia gravis with thymona, patients with myasthenia gravis without thymona, and patients with thymona without myasthenia gravis.
Hypothesis: The T-cells which are generated in the thymoma in thymoma-associated myasthenia gravis can be differentiated from T-cells which are generated in normal thymoma tissue with regard to functionality and T-cell receptor specificity. This non-physiological T-cell maturation might be the cause for the formation of auto-antibodies.
On the other hand we want to examine the effects of thymectomy on the immune system in the context of myasthenia gravis. We will analyse blood and thymoma tissue of patients with myasthenia gravis with thymona, patients with myasthenia gravis without thymona, patients with thymona without myasthenia gravis and patients with cardiac, or thyroid surgery.
Hypothesis:
- Thymectomy in patients with myasthenia gravis leads to a reduced number of auto-reactive, e.g. Acetylcholine receptor (ACh-R)-specific T cells. In contrast, T-cells with other specifities, for example against CMV or tetanus, are not affected.
- The non-physiological export of thymocytes from thymomas leads to a significant shift in leukocyte populations in peripheral blood.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Charite University (Dept of Neurology & NeuroCure Clinical Research Center NCRC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with compelling indications for thymectomy due to thymoma (with or without myasthenia gravis), Or
- Patients with elective indication for thymectomy due to thymoma without myasthenia gravis
- Patients with indication for a heart or thyroid surgery, in which for op-technical reasons, a (partial) resection of the thymus is performed.
- Signed informed consent form
- Age > 17 Years
Exclusion Criteria:
- Other immunological diseases such as rheumatoid arthritis, multiple sclerosis
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Myasthenia gravis with thymoma
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Myasthenia gravis without thymoma
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Thymoma without Myasthenia gravis
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cardiac, or thyroid surgery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andreas Meisel, MD, Charite University, Berlin, Germany
Publications and helpful links
General Publications
- Kohler S, Keil T, Alexander T, Thiel A, Swierzy M, Ismail M, Ruckert JC, Meisel A. Altered naive CD4+ T cell homeostasis in myasthenia gravis and thymoma patients. J Neuroimmunol. 2019 Feb 15;327:10-14. doi: 10.1016/j.jneuroim.2019.01.005. Epub 2019 Jan 11.
- Kohler S, Keil TOP, Hoffmann S, Swierzy M, Ismail M, Ruckert JC, Alexander T, Meisel A. CD4+ FoxP3+ T regulatory cell subsets in myasthenia gravis patients. Clin Immunol. 2017 Jun;179:40-46. doi: 10.1016/j.clim.2017.03.003. Epub 2017 Mar 9.
- Kohler S, Keil TO, Swierzy M, Hoffmann S, Schaffert H, Ismail M, Ruckert JC, Alexander T, Hiepe F, Gross C, Thiel A, Meisel A. Disturbed B cell subpopulations and increased plasma cells in myasthenia gravis patients. J Neuroimmunol. 2013 Nov 15;264(1-2):114-9. doi: 10.1016/j.jneuroim.2013.09.006. Epub 2013 Sep 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Thoracic Neoplasms
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Nervous System Neoplasms
- Neoplasms, Complex and Mixed
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Thymoma
- Thymus Neoplasms
- Myasthenia Gravis
Other Study ID Numbers
- Thymus in myasthenia gravis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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