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

Thymoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02948855
• Other study ID #: bc2016031
• Status: Withdrawn
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Thymoma
• Thymus Neoplasms

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Bray SJ. Notch signalling: a simple pathway becomes complex. Nat Rev Mol Cell Biol. 2006 Sep;7(9):678-89. Review. — View Citation

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. — View Citation

Klinker MW, Lundy SK. Multiple mechanisms of immune suppression by B lymphocytes. Mol Med. 2012 Feb 10;18:123-37. doi: 10.2119/molmed.2011.00333. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Ströbel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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	2016.10.01~2018.09.31-up to 24 months