NCT01102192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

5.3 years

First QC Date

April 12, 2010

Last Update Submit

July 8, 2020

Conditions

Myasthenia GravisThymoma

Keywords

Myasthenia gravisThymomaT-cellsThymectomy

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Other immunological diseases such as rheumatoid arthritis, multiple sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University (Dept of Neurology & NeuroCure Clinical Research Center NCRC)

Berlin, 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 30686546RESULT

  • 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.

    PMID: 28286113RESULT

  • 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.

    PMID: 24099983RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (serum, plasma), Thymoma tissue

MeSH Terms

Conditions

Myasthenia GravisThymoma

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic TypeThymus NeoplasmsThoracic NeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andreas Meisel, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

August 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

DE(1)