ThymomaNCT02948855
Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases
An observational study of Thymoma and Autoimmune Disease, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thymoma, Autoimmune Disease
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (1) The patients with the diagnosis of mediastinal tumors (thymoma, thymic hyperplasia);
- The patients with the diagnosis of autoimmune diseases;
- Age of 18 years or older which expected to stay in ICU for≥5 days.
- APACHE II score > 15;
- The patients or authorized clients agree to participate in the clinical trial and sign the informed consent.
Who cannot join
- (1) the patients with circulatory, respiratory failure and major organ dysfunction after being endangered and transferred to ICU;
- patients with severe liver and renal dysfunction;
- pregnant or lactating women;
- patients who have not signed the informed consent;
- any factors that may be expected to increase the risk of patients or other factors that may interfere with the outcome of clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Study on Regulation of LncRNA to Regulatory B Cells(Bregs) Through Notch Pathway in Patients With Thymoma and Autoimmune Diseases
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.
Read the detailed description
- This study plans to research the correlation between Bregs and thymoma complicated with autoimmune diseases and the regulation the severity of the disease.
- Clarify different expression levels of Notch2 signaling pathway in thymoma complicated with autoimmune diseases, and the effect on Regulatory B Cells(Bregs).
- Find the effective regulation mode of Notch2 signaling pathway and the regulation of Bregs cell development and function in LncRNA.
- Conditions
- Thymoma, Autoimmune Disease
- Keywords
- Long non-coding RNA（LncRNA）, Thymoma, Autoimmune disease, Notch2 Signaling pathway, Regulatory B cell（Breg）
- Medical subject headings
- Thymoma, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2016.10.01~2018.09.31-up to 24 months
Secondary outcomes (1)
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
Measured: 2016.10.01~2018.09.31-up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Improper design of the trial and no participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donghao Wang, director, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948855
- Sponsor's protocol ID
- bc2016031
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Strobel 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.
PubMed 24236644Kessel 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.
PubMed 22155204Klinker MW, Lundy SK. Multiple mechanisms of immune suppression by B lymphocytes. Mol Med. 2012 Feb 10;18(1):123-37. doi: 10.2119/molmed.2011.00333.
PubMed 22033729Bray SJ. Notch signalling: a simple pathway becomes complex. Nat Rev Mol Cell Biol. 2006 Sep;7(9):678-89. doi: 10.1038/nrm2009.
PubMed 16921404Matsumoto 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.
PubMed 25484301Mauri 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.
PubMed 26071023
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Regulation of LncRNA to Regulatory B Cells(Bregs) Through Notch Pathway in Patients With Thymoma and Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT02948855
- Acronym / sponsor ID
- bc2016031
- Conditions
- Thymoma, Autoimmune Disease
- Keywords
- Long non-coding RNA（LncRNA）, Thymoma, Autoimmune disease, Notch2 Signaling pathway, Regulatory B cell（Breg）
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Improper design of the trial and no participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- This study plans to research the correlation between Bregs and thymoma complicated with autoimmune diseases and the regulation the severity of the disease.
- Clarify different expression levels of Notch2 signaling pathway in thymoma complicated with autoimmune diseases, and the effect on Regulatory B Cells(Bregs).
- Find the effective regulation mode of Notch2 signaling pathway and the regulation of Bregs cell development and function in LncRNA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- (1) The patients with the diagnosis of mediastinal tumors (thymoma, thymic hyperplasia);
Key exclusion criteria (5 listed)
- (1) the patients with circulatory, respiratory failure and major organ dysfunction after being endangered and transferred to ICU;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 24236644Strobel 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.
- Background: PubMed 22155204Kessel 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.
- Background: PubMed 22033729Klinker MW, Lundy SK. Multiple mechanisms of immune suppression by B lymphocytes. Mol Med. 2012 Feb 10;18(1):123-37. doi: 10.2119/molmed.2011.00333.
- Background: PubMed 16921404Bray SJ. Notch signalling: a simple pathway becomes complex. Nat Rev Mol Cell Biol. 2006 Sep;7(9):678-89. doi: 10.1038/nrm2009.
- Background: PubMed 25484301Matsumoto 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.
- Background: PubMed 26071023Mauri 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donghao Wang, director study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymoma and Autoimmune Disease, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between LncRNA and Notch2 signaling pathway (time frame: 2016.10.01~2018.09.31-up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948855, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.