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

Withdrawn

• Conditions: Thymoma; Autoimmune Disease

• Registration Number: NCT02948855
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

1. This study plans to research the correlation between Bregs and thymoma complicated with autoimmune diseases and the regulation the severity of the disease.

2. Clarify different expression levels of Notch2 signaling pathway in thymoma complicated with autoimmune diseases, and the effect on Regulatory B Cells(Bregs).

3. Find the effective regulation mode of Notch2 signaling pathway and the regulation of Bregs cell development and function in LncRNA.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-31
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relationship between LncRNA and Notch2 signaling pathway	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.

Secondary Outcome Measures

Name	Time	Method
The regulated effect of Notch2 signaling pathway to the development of Bregs and the cell function	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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China