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

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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Recruitment Status : Withdrawn (Improper design of the trial and no participants enrolled.)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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Thymoma Autoimmune Disease

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Tm group
Simple thymoma group:The patients have suffered thymoma only and have no other complications.
Tm+MG group
Thymoma complicated with myasthenia gravis (MG) group: The patients have suffered thymoma and myasthenia gravis in the mean time.
Tm+MG+AD group

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  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.
Criteria

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.


Information from the National Library of Medicine

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


Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Director: Donghao Wang, director Tianjin Medical University Cancer Institute and Hospital

Publications:
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02948855     History of Changes
Other Study ID Numbers: bc2016031
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Long non-coding RNA(LncRNA)
Thymoma
Autoimmune disease
Notch2 Signaling pathway
Regulatory B cell(Breg)
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Autoimmune Diseases
Immune System Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases