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Clinical Trials/NCT02948855
NCT02948855WithdrawnNot Applicable

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

Tianjin Medical University Cancer Institute and Hospital1 site in 1 countryStarted: October 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
The relationship between LncRNA and Notch2 signaling pathway

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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