The Role of the Thymus in Myasthenia Gravis | NCT01102192

Studies
The Role of the Thymus in Myasthenia Gravis

NCT01102192

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 10, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Myasthenia Gravis
Thymoma

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 12, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2020

Last Update Posted Date

Jul 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Meisel, Prof. Dr., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
NeuroCure Clinical Research Center, Charite, Berlin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Meisel, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University (Dept of Neurology & NeuroCure Clinical Research Center NCRC)		Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30686546	Result	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.
28286113	Result	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.

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms