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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01668381
First received: March 18, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention
Hepatocellular Carcinoma
Procedure: radiofrequency ablation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 18, 2012
Last Updated: February 20, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by 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
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 21, 2014