Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases

Study Overview
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Brief Summary
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Initially investigators will find LncRNA which to be able to affect Notch2 signaling pathway; then confirm the relationship between Notch2 and LncRNA, and analysis the regulation mode of LncRNA to Notch2 signaling pathway, and to observe the correlation between LncRNA and thymoma complicated with autoimmune diseases.

Detailed Description
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This study plans to research the correlation between Bregs and thymoma complicated with autoimmune diseases and the regulation the severity of the disease. Clarify different expression levels of Notch2 signaling pathway in thymoma complicated with autoimmune diseases, and the effect on Regulatory B Cells(Bregs). Find the effective regulation mode of Notch2 signaling pathway and the regulation of Bregs cell development and function in LncRNA.

Official Title
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Study on Regulation of LncRNA to Regulatory B Cells(Bregs) Through Notch Pathway in Patients With Thymoma and Autoimmune Diseases

Conditions
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Thymoma, Autoimmune Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) The patients with the diagnosis of mediastinal tumors (thymoma, thymic hyperplasia); (2) The patients with the diagnosis of autoimmune diseases; (3) Age of 18 years or older which expected to stay in ICU for≥5 days. (4) APACHE II score > 15; (5) The patients or authorized clients agree to participate in the clinical trial and sign the informed consent. Exclusion Criteria: (1) the patients with circulatory, respiratory failure and major organ dysfunction after being endangered and transferred to ICU; (2) patients with severe liver and renal dysfunction; (3) pregnant or lactating women; (4) patients who have not signed the informed consent; (5) any factors that may be expected to increase the risk of patients or other factors that may interfere with the outcome of clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tm group<br>Simple thymoma group：The patients have suffered thymoma only and have no other complications. | |
| Tm+MG group<br>Thymoma complicated with myasthenia gravis (MG) group: The patients have suffered thymoma and myasthenia gravis in the mean time. | |
| Tm+MG+AD group<br>Thymoma complicated with myasthenia gravis and other autoimmune diseases (AD) group: The patients have suffered thymoma, myasthenia gravis and other autoimmune diseases in the mean time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between LncRNA and Notch2 signaling pathway | Using of Real-Time Polymerase Chain Reaction(RT-PCR) and Western-Blot to find special LncRNA that can affect the Notch2 signaling pathway LncRNA's and Notch2 signaling pathway's gene and protein expression level Then, using of SiRNA to inhibit the expression of LncRNA or plasmid transfection to raise the expression of LncRNA, and observation of changes of Notch2 signaling pathway. | 2016.10.01 2018.09.31-up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The regulated effect of Notch2 signaling pathway to the development of Bregs and the cell function | Peripheral blood was obtained from participants, and Regulatory B Cells(Bregs) were extracted and cultured. SiRNA-Notch2 to inhibit the expression of Notch2 signaling pathway and plasmid transfection of Notch2 to raise the expression of Notch2 signaling pathway, Then, observation of the quantity (*10^6/ml) and morphological changes of Bregs; the expression differences of Notch2 signaling pathway and content level (pg/ml) of Interleukin-10 (IL-10) in culture supernatant | 2016.10.01 2018.09.31-up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long non-coding RNA（LncRNA）, Thymoma, Autoimmune disease, Notch2 Signaling pathway, Regulatory B cell（Breg）