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Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy

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ClinicalTrials.gov Identifier: NCT01668381
Recruitment Status : Unknown
Verified February 2013 by Ming Kuang,MD,PhD, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2012
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
Guangdong Province, Department of Science and Technology
Information provided by (Responsible Party):
Ming Kuang,MD,PhD, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
The purpose of this study is to determine the enumeration and function changes of regulatory t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation therapy.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Procedure: radiofrequency ablation

Detailed Description:
Regulatory T cells,which are also called Treg cells,play an important role in suppressing anti-tumor immunity.Accumulated evidences indicate that Treg cells are elevated in peripheral blood,however,there are also reports that decreased Treg cells are found in hepatocellular patients.This study focuses on the changes of Treg cells ratio in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation ,also its functional cytokines,such as TGF-β,IL-10,IFN-γ,and inhibition function when co-cultured with CD4+CD25-、CD8+ cells. The investigators speculate that a decreased Treg ratio will be found in patients who receive ablation therapy,and its function cytokines,moreover,CD4+CD25-、CD8+ cells' proliferation and function could be inhibited when co-cultured with Treg cells.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy
Study Start Date : August 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

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U.S. FDA Resources

Group/Cohort Intervention/treatment
HCC patients
Hepatocellular carcinoma patients treated by radiofrequency ablation
Procedure: radiofrequency ablation
the patients are prepared by local anesthesia and intravenous sedative.guided by the ultrasound,the antenna used for radiofrequency ablation ablation is placed in the tumor to destroy tumor tissues,the output power and duration are depended by the tumor volume and location.



Primary Outcome Measures :
  1. variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy [ Time Frame: 4 weeks post therapy ]
    changes of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,such as CD3+,CD4+,CD8+,CD4+CD25+FOXP3+(Treg) cells.

  2. variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy [ Time Frame: 4 weeks post therapy ]
    variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy


Secondary Outcome Measures :
  1. variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy [ Time Frame: 4 weeks post therapy ]
    CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.CD4+CD25- and CD8+ T cells proliferation changes were analysed to test CD4+CD25+ T cell suppression ability.

  2. variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy [ Time Frame: 4 weeks post therapy ]
    CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.supernatant IFN-γ were analysed to test CD4+CD25+ T cell suppression ability.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hepatocellular carcinoma patients underwent radiofrequency ablation therapy
Criteria

Inclusion Criteria:

  • hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of hepatocellular carcinoma and alphafetoprotein>400μg/L;or two or more dynamic imagine with a diagnosis of hepatocellular carcinoma
  • Child-Pugh A or B
  • well preserved renal and hematopoietic Function
  • receive ablation therapy through percutaneous radiofrequency ablation or microwave ablation or ethanol injection ablation or any kind of combination of them.
  • achieve complete ablation accessed by contrast-enhanced CT

Exclusion Criteria:

  • incomplete ablation
  • remote metastasis
  • Child-Pugh C
  • general infection
  • autoimmune diseases
  • suffer from other tumors concurrently or in last five years
  • patients with immune deficit or infected by HIV
  • receiving glucocorticoid or other medicine inhibiting immune system

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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): NCT01668381


Locations
China, Guangdong
Sun Yat-Sen University,First Affiliated Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Province, Department of Science and Technology
Investigators
Study Chair: Ming Kuang, MD,PhD First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Qing-qi Ren, Bachelor First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Ming Kuang,MD,PhD, MD,PhD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01668381     History of Changes
Other Study ID Numbers: 2010B031600209
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Ming Kuang,MD,PhD, First Affiliated Hospital, Sun Yat-Sen University:
hepatocellular carcinoma
Catheter Ablation
T-Lymphocytes, Regulatory
IL-10
TGF-β
IFN-γ

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases