The Role of the Thymus in Myasthenia Gravis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01102192
First received: April 12, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

Although the association between thymic hyperplasia / thymoma and autoimmune myasthenia gravis has been known for some time, the question of causality remains uncertain. Recent research findings indicate, however, that especially in myasthenia patients with thymomas a non-physiological export of naive CD4 + T-cells can take place by the tumour and this could possibly play an important role in the pathogenesis of myasthenia gravis. The investigators want to analyse the functionality and specificity of t-cells generated in thymomas as well as the effect of thymectomy on the immune system.


Condition
Myasthenia Gravis
Thymoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Biospecimen Retention:   Samples Without DNA

Blood sample (serum, plasma), Thymoma tissue


Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Myasthenia gravis with thymoma
Myasthenia gravis with thymoma
Myasthenia gravis without thymoma
Myasthenia gravis without thymoma
Thymoma without Myasthenia gravis
Thymoma without Myasthenia gravis
cardiac, or thyroid surgery
cardiac, or thyroid surgery

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:

  1. 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.
  2. The non-physiological export of thymocytes from thymomas leads to a significant shift in leukocyte populations in peripheral blood.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with and without Mystenia gravis (with and without thymona) and patients with an indication for a heart or thyroid surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102192

Locations
Germany
Charite University (Dept of Neurology & NeuroCure Clinical Research Center NCRC)
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01102192     History of Changes
Other Study ID Numbers: Thymus in myasthenia gravis
Study First Received: April 12, 2010
Last Updated: September 22, 2014
Health Authority: Germany: Ethics Commission of the Charité University Berlin

Keywords provided by Charite University, Berlin, Germany:
Myasthenia gravis
Thymoma
T-cells
Thymectomy

Additional relevant MeSH terms:
Myasthenia Gravis
Thymoma
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Immune System Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Nervous System Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Thoracic Neoplasms
Thymus Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014