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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02948855
Enrollment
0
Registered
2016-10-31
Start date
2016-10-31
Completion date
2018-05-31
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease, Thymoma

Keywords

Long non-coding RNA(LncRNA), Thymoma, Autoimmune disease, Notch2 Signaling pathway, Regulatory B cell(Breg)

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.

Interventions

None listed

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The relationship between LncRNA and Notch2 signaling pathway2016.10.01~2018.09.31-up to 24 monthsUsing 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

MeasureTime frameDescription
The regulated effect of Notch2 signaling pathway to the development of Bregs and the cell function2016.10.01~2018.09.31-up to 24 monthsPeripheral 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

Other

MeasureTime frameDescription
The relevance of Bregs and thymoma with autoimmune diseases2016.10.01~2018.09.31-up to 24 monthsNatural 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026