Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02948855|
Recruitment Status : Withdrawn (Improper design of the trial and no participants enrolled.)
First Posted : October 31, 2016
Last Update Posted : May 18, 2018
|Condition or disease|
|Thymoma Autoimmune Disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Study on Regulation of LncRNA to Regulatory B Cells(Bregs) Through Notch Pathway in Patients With Thymoma and Autoimmune Diseases|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
Simple thymoma group：The patients have suffered thymoma only and have no other complications.
Thymoma complicated with myasthenia gravis (MG) group: The patients have suffered thymoma and myasthenia gravis in the mean time.
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.
- The relationship between LncRNA and Notch2 signaling pathway [ Time Frame: 2016.10.01~2018.09.31-up to 24 months ]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.
- The regulated effect of Notch2 signaling pathway to the development of Bregs and the cell function [ Time Frame: 2016.10.01~2018.09.31-up to 24 months ]
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
- The relevance of Bregs and thymoma with autoimmune diseases [ Time Frame: 2016.10.01~2018.09.31-up to 24 months ]
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.
Biospecimen Retention: Samples With DNA
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948855
|Tianjin Medical University Cancer Institute and Hospital|
|Tianjin, Tianjin, China, 300060|
|Study Director:||Donghao Wang, director||Tianjin Medical University Cancer Institute and Hospital|