The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between Clinical Prognosis and Regulatory T Cell Expression (Tregs)
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Staging surgery or debulking surgery
Sponsored by
About this trial
This is an interventional basic science trial for Ovarian Cancer
Eligibility Criteria
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:
-
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00854282
First Posted
March 1, 2009
Last Updated
March 2, 2009
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00854282
Brief Title
The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between Clinical Prognosis and Regulatory T Cell Expression
Acronym
Tregs
Official Title
The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Staging surgery or debulking surgery
Intervention Description
Staging surgery or debulking surgery
Primary Outcome Measure Information:
Title
overall survival
Time Frame
from disease diagnosis to death
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Fang Cheng, Associated Professor
Phone
886-2-23123456
Ext
65166
Email
wenfangcheng@yahoo.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Fang Cheng, Associated Professor
Phone
886-2-23123456
Ext
65166
Email
wenfangcheng@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between Clinical Prognosis and Regulatory T Cell Expression
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