The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between Clinical Prognosis and Regulatory T Cell Expression

Ovarian Cancer Clinical Trial

— Tregs  

Official title:

The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00854282
• Other study ID #: 200812139R
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2009
• Last updated: March 2, 2009
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2009
• Source: National Taiwan University Hospital
• Contact: Wen-Fang Cheng, Associated Professor
• Phone: 886-2-23123456
• Email: wenfangcheng[@]yahoo.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Cancer is the leading cause of mortality in our country, and ovarian cancer becomes a more and more important disease gradually in the field of gynecologic malignancies. According to the statistics of the Department of Health, the incidence of ovarian cancer increased in recent years and the mortality rate was the highest among all gynecologic malignancies in Taiwan. Early diagnosis for ovarian cancer is difficult due to the lack of obvious and specific initial symptoms. Therefore, it is usually at advanced stage when the diagnosis is confirmed. The prognostic parameters for ovarian cancer include tumor stage, histological subtype and grade, residual tumor after surgical intervention and the response to chemotherapy. However, the possible mechanism of ovarian cancer is still not clear now, which has considerable influence on the management and prognosis of the patients.

Malignancy is considered as a multi-factorial disease, and the influence of immunologic mechanism on progression and prognosis of cancer is more and more important. The natural CD25+CD4+ regulatory T cells actively suppress pathologic and physiological immune response, contributing to the maintenance of immunological self-tolerance and immune homeostasis. The development and function of regulatory T cells depend on the expression of the transcription factor forkhead box P3 (FOXP3). The mechanisms of suppression are still not known well. Whatever the mechanisms of suppression are, it is necessary to control the magnitude of regulatory T cells-mediated suppression for the benefit of the host because too much suppression might lead to immunosuppression and render the host susceptible to infection and cancer.

We will collect the tumor tissue, ascites and peripheral blood during operation. Through this research we will set up the immunological profiles in the changes of lymphocytes, humoral immunity and cell-mediated immunity in ovarian cancer patients. The kinetic changes and associations between regulatory T cells and the severity and progression of disease will also be evaluated. Therefore, the role of regulatory T cells would be defined in the patients with ovarian cancer. We will also correlate the regulatory T cells with the clinical prognosis of ovarian cancer patients. Finally, we will try to find an efficient therapeutic strategy for the cancer patients.

Description:

Methods:

All of the patients received four to six courses of adjuvant platinum-containing chemotherapy.Histologic grading was according to International Union against Cancer criteria (28). The stage of disease was classified according to the International Federation of Gynecology and Obstetrics (FIGO, 1987). Pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. The histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. The maximal diameter of the residual tumor after surgery will be also recorded. All patients will be followed up at 3-month intervals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with ovarian carcinoma who undergo hysterectomy, bilateral oophorectomy and tubal resection, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital.

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Staging surgery or debulking surgery
Staging surgery or debulking surgery

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		from disease diagnosis to death	No