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

March 2, 2009 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: from disease diagnosis to death
from disease diagnosis to death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 1, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 3, 2009

Last Update Submitted That Met QC Criteria

March 2, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200812139R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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