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

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ClinicalTrials.gov Identifier: NCT00854282
Recruitment Status : Unknown
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 3, 2009
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment
Ovarian Cancer Procedure: Staging surgery or debulking surgery

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Regulatory T Cell in Ovarian Cancer: Focus on Relationship Between
Study Start Date : January 2009
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Intervention Details:
    Procedure: Staging surgery or debulking surgery
    Staging surgery or debulking surgery


Primary Outcome Measures :
  1. overall survival [ Time Frame: from disease diagnosis to death ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854282


Contacts
Contact: Wen-Fang Cheng, Associated Professor 886-2-23123456 ext 65166 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Fang Cheng, Associated Professor    886-2-23123456 ext 65166    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: Wen-Fang Cheng/Associate Professor, National Taiwan Unviersity Hospital
ClinicalTrials.gov Identifier: NCT00854282     History of Changes
Other Study ID Numbers: 200812139R
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders