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Improper design of the trial and no participants enrolled.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tm group | Simple thymoma group：The patients have suffered thymoma only and have no other complications. | ||
| Tm+MG group | Thymoma complicated with myasthenia gravis (MG) group: The patients have suffered thymoma and myasthenia gravis in the mean time. | ||
| Tm+MG+AD group | 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. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The relevance of Bregs and thymoma with autoimmune diseases | Natural disease course (number of days) Treatment options: hormone dosage (mg), cytotoxic drug dosage (mg), 28 day mortality (%), treatment success rate. Laboratory examination: white blood cell (*10^9/L), hemoglobin (g/L), urinary protein (mg/L), titers of autoimmune antibody. Vital signs: heart rate (bpm), body temperature. | 2016.10.01~2018.09.31-up to 24 months |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Donghao Wang, director | Tianjin Medical University Cancer Institute and Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24236644 | Background | Strobel P, Hartmann E, Rosenwald A, Kalla J, Ott G, Friedel G, Schalke B, Kasahara M, Tomaru U, Marx A. Corticomedullary differentiation and maturational arrest in thymomas. Histopathology. 2014 Mar;64(4):557-66. doi: 10.1111/his.12279. Epub 2013 Nov 18. | |
| 22155204 | Background | Kessel A, Haj T, Peri R, Snir A, Melamed D, Sabo E, Toubi E. Human CD19(+)CD25(high) B regulatory cells suppress proliferation of CD4(+) T cells and enhance Foxp3 and CTLA-4 expression in T-regulatory cells. Autoimmun Rev. 2012 Jul;11(9):670-7. doi: 10.1016/j.autrev.2011.11.018. Epub 2011 Dec 2. |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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The patients of Thymoma complicated with autoimmune diseases:
Thymoma tissues Lymph glands Peripheral blood Thymoma tissues and Lymph glands will be retained formalin and -80℃ refrigerator.
Peripheral blood will be detected by flow cytometry.
| 2016.10.01~2018.09.31-up to 24 months |
| 22033729 | Background | Klinker MW, Lundy SK. Multiple mechanisms of immune suppression by B lymphocytes. Mol Med. 2012 Feb 10;18(1):123-37. doi: 10.2119/molmed.2011.00333. |
| 16921404 | Background | Bray SJ. Notch signalling: a simple pathway becomes complex. Nat Rev Mol Cell Biol. 2006 Sep;7(9):678-89. doi: 10.1038/nrm2009. |
| 25484301 | Background | Matsumoto M, Baba A, Yokota T, Nishikawa H, Ohkawa Y, Kayama H, Kallies A, Nutt SL, Sakaguchi S, Takeda K, Kurosaki T, Baba Y. Interleukin-10-producing plasmablasts exert regulatory function in autoimmune inflammation. Immunity. 2014 Dec 18;41(6):1040-51. doi: 10.1016/j.immuni.2014.10.016. Epub 2014 Nov 4. |
| 26071023 | Background | Mauri C, Menon M. The expanding family of regulatory B cells. Int Immunol. 2015 Oct;27(10):479-86. doi: 10.1093/intimm/dxv038. Epub 2015 Jun 12. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |