Clinical trial NCT01668381: Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy
Official title: Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Catheter Ablation
T-Lymphocytes, Regulatory
IL-10
TGF-β
IFN-γ
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Province, Department of Science and Technology
First posted: 2012-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hepatocellular carcinoma patients underwent radiofrequency ablation therapy

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.

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 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

Primary outcomes:
measure: variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
timeFrame: 4 weeks post therapy
measure: variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
timeFrame: 4 weeks post therapy
Secondary outcomes:
measure: variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
timeFrame: 4 weeks post therapy
measure: variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy
timeFrame: 4 weeks post therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University,First Affiliated Hospital
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, MD,PhD
role: STUDY_CHAIR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Qing-qi Ren, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: