The Role of the Thymus in Myasthenia Gravis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01102192
First received: April 12, 2010
Last updated: February 19, 2013
Last verified: February 2013

April 12, 2010
February 19, 2013
August 2007
December 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01102192 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Role of the Thymus in Myasthenia Gravis
Not Provided

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood sample (serum, plasma), Thymoma tissue

Non-Probability Sample

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

  • Myasthenia Gravis
  • Thymoma
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01102192
Thymus in myasthenia gravis
No
Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Andreas Meisel, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP