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

NCT01668381 | Unknown

• 1 other identifier: 2010B031600209
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; Catheter Ablation; T-Lymphocytes, Regulatory; IL-10; TGF-β; IFN-γ

Outcome Measures

Primary Outcomes (2)

• variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation 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.

  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

  variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

  4 weeks post therapy

Secondary Outcomes (2)

• variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

  4 weeks post therapy

• variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy

  4 weeks post therapy

Study Arms (1)

HCC patients

Hepatocellular carcinoma patients treated by radiofrequency ablation

Procedure: radiofrequency ablation

Interventions

radiofrequency ablation PROCEDURE

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.

HCC patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hepatocellular carcinoma patients underwent radiofrequency ablation therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Guangdong Province, Department of Science and Technology: collaborator

Study Sites (1)

Sun Yat-Sen University,First Affiliated Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ming Kuang, MD,PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

• Qing-qi Ren, Bachelor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

CN (1)