4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients

Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients

Study Description
Brief Summary:
Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.

Condition or disease Intervention/treatment
Thrombocytopenia Splenectomy Procedure: splenectomy

Detailed Description:

A total of 30 ITP patients will be enrolled in the study. These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy. Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital. The investigators plan to take 20ml of peripheral blood (PB) of these patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and take a small amount of spleen tissue during surgery.

18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood. The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to Hereditary spherocytosis or trauma.

And then the investigators will do the experiments step by step. 1, Isolation of peripheral blood and splenic mononuclear cells;2, Detection of the percentage of cell population;3, Activation and proliferation of B lymphocyte; 4, Activation and proliferation of T lymphocyte;5,Apoptosis of platelets by cytotoxic T cells;6,Phagocytosis of platelets by macrophages in spleen;7,Enzyme-linked immunosorbent assay (ELISA) for cytokines.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 23, 2022
Estimated Study Completion Date : July 23, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
30 immune thrombocytopenia(ITP) patients
A total of 30 cases. The investigators plan to take 20ml of peripheral blood (PB) of these 30 ITP patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
 Procedure: splenectomy
These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy.Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital.
20 normal controls
A total of 20 cases.18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood.
Spleens of the 30 cases patients(ITP)
These 30 ITP patients agree to have splenectomy.The investigators will take a small amount of spleen tissue during surgery.
Spleens of the 10 cases patients(normal controls)
The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to hereditary spherocytosis or trauma.
Outcome Measures
Primary Outcome Measures :
  1. Changes of the percentage of cell population [ Time Frame: 1 year ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets and the functionally-polarized CD4+ T cell subsets in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  2. Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) [ Time Frame: 1 year ]
    To assess the changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  3. Changes of cytokines in the cell culture supernatants and plasma [ Time Frame: 1 year ]
    To assess the changes of cytokines in the cell culture supernatants and plasma at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.


Secondary Outcome Measures :
  1. Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.

  2. Changes of the percentage of cell population, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets ,the functionally-polarized CD4+ T cell subsets, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.
Criteria

Inclusion Criteria:

  • Aged 18 to 60 years old, male or female;
  • Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
  • Needed splenectomy;
  • People who are willing to sign the informed consent voluntarily and follow the research program.

Exclusion Criteria:

  • Secondary thrombocytopenic purpura;
  • Patients with poor compliance;
  • Researchers believe that patients should not participate in the test of any other condition.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yunfei Chen, MD +86-22-23909009 chenyunfei@ihcams.ac.cn
Contact: Lei Zhang, MD +86-22-23909240 zhanglei1@ihcams.ac.cn

Locations
Layout table for location information
China, Tianjin
Yunfei Chen Recruiting
Tianjin, Tianjin, China, 300020
Contact: Yunfei Chen, Doctor    +86-22-23909009    chenyunfei@ihcams.ac.cn   
Sponsors and Collaborators
Zhang Lei
Investigators
Layout table for investigator information
Principal Investigator: Lei Zhang, MD Chinese Academy of Medical Science and Blood Disease Hospital
Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 25, 2019
Last Update Posted Date July 21, 2020
Actual Study Start Date January 23, 2019
Estimated Primary Completion Date January 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019)
  • Changes of the percentage of cell population [ Time Frame: 1 year ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets and the functionally-polarized CD4+ T cell subsets in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.
  • Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) [ Time Frame: 1 year ]
    To assess the changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.
  • Changes of cytokines in the cell culture supernatants and plasma [ Time Frame: 1 year ]
    To assess the changes of cytokines in the cell culture supernatants and plasma at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2019)
  • Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.
  • Changes of the percentage of cell population, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets ,the functionally-polarized CD4+ T cell subsets, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Official Title Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Brief Summary Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.
Detailed Description

A total of 30 ITP patients will be enrolled in the study. These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy. Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital. The investigators plan to take 20ml of peripheral blood (PB) of these patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and take a small amount of spleen tissue during surgery.

18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood. The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to Hereditary spherocytosis or trauma.

And then the investigators will do the experiments step by step. 1, Isolation of peripheral blood and splenic mononuclear cells;2, Detection of the percentage of cell population;3, Activation and proliferation of B lymphocyte; 4, Activation and proliferation of T lymphocyte;5,Apoptosis of platelets by cytotoxic T cells;6,Phagocytosis of platelets by macrophages in spleen;7,Enzyme-linked immunosorbent assay (ELISA) for cytokines.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.
Condition
  • Thrombocytopenia
  • Splenectomy
Intervention Procedure: splenectomy
These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy.Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital.
Study Groups/Cohorts
  • 30 immune thrombocytopenia(ITP) patients
    A total of 30 cases. The investigators plan to take 20ml of peripheral blood (PB) of these 30 ITP patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
    Intervention: Procedure: splenectomy
  • 20 normal controls
    A total of 20 cases.18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood.
  • Spleens of the 30 cases patients(ITP)
    These 30 ITP patients agree to have splenectomy.The investigators will take a small amount of spleen tissue during surgery.
  • Spleens of the 10 cases patients(normal controls)
    The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to hereditary spherocytosis or trauma.
Publications *
  • Olsson B, Ridell B, Jernås M, Wadenvik H. Increased number of B-cells in the red pulp of the spleen in ITP. Ann Hematol. 2012 Feb;91(2):271-7. doi: 10.1007/s00277-011-1292-2. Epub 2011 Jul 23.
  • Kuwana M, Okazaki Y, Kaburaki J, Kawakami Y, Ikeda Y. Spleen is a primary site for activation of platelet-reactive T and B cells in patients with immune thrombocytopenic purpura. J Immunol. 2002 Apr 1;168(7):3675-82.
  • Zhang F, Chu X, Wang L, Zhu Y, Li L, Ma D, Peng J, Hou M. Cell-mediated lysis of autologous platelets in chronic idiopathic thrombocytopenic purpura. Eur J Haematol. 2006 May;76(5):427-31. Epub 2006 Feb 15.
  • Liu B, Zhao H, Poon MC, Han Z, Gu D, Xu M, Jia H, Yang R, Han ZC. Abnormality of CD4(+)CD25(+) regulatory T cells in idiopathic thrombocytopenic purpura. Eur J Haematol. 2007 Feb;78(2):139-43.
  • Ling Y, Cao X, Yu Z, Ruan C. Circulating dendritic cells subsets and CD4+Foxp3+ regulatory T cells in adult patients with chronic ITP before and after treatment with high-dose dexamethasome. Eur J Haematol. 2007 Oct;79(4):310-6. Epub 2007 Aug 10.
  • Olsson B, Ridell B, Carlsson L, Jacobsson S, Wadenvik H. Recruitment of T cells into bone marrow of ITP patients possibly due to elevated expression of VLA-4 and CX3CR1. Blood. 2008 Aug 15;112(4):1078-84. doi: 10.1182/blood-2008-02-139402. Epub 2008 Jun 2.
  • McMillan R, Wang L, Tani P. Prospective evaluation of the immunobead assay for the diagnosis of adult chronic immune thrombocytopenic purpura (ITP). J Thromb Haemost. 2003 Mar;1(3):485-91.
  • Yu J, Heck S, Patel V, Levan J, Yu Y, Bussel JB, Yazdanbakhsh K. Defective circulating CD25 regulatory T cells in patients with chronic immune thrombocytopenic purpura. Blood. 2008 Aug 15;112(4):1325-8. doi: 10.1182/blood-2008-01-135335. Epub 2008 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 24, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 23, 2022
Estimated Primary Completion Date January 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 18 to 60 years old, male or female;
  • Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
  • Needed splenectomy;
  • People who are willing to sign the informed consent voluntarily and follow the research program.

Exclusion Criteria:

  • Secondary thrombocytopenic purpura;
  • Patients with poor compliance;
  • Researchers believe that patients should not participate in the test of any other condition.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yunfei Chen, MD +86-22-23909009 chenyunfei@ihcams.ac.cn
Contact: Lei Zhang, MD +86-22-23909240 zhanglei1@ihcams.ac.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03998059
Other Study ID Numbers KT2018087-EC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zhang Lei, Institute of Hematology & Blood Diseases Hospital
Study Sponsor Zhang Lei
Collaborators Not Provided
Investigators
Principal Investigator: Lei Zhang, MD Chinese Academy of Medical Science and Blood Disease Hospital
PRS Account Institute of Hematology & Blood Diseases Hospital
Verification Date July 2020

治疗医院

新药特效药

前沿医讯