The Assessment of Mesothelin Antigen Specific Immunologic Assays in Ovarian Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00173394|
Recruitment Status : Unknown
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : December 19, 2006
Ovarian cancer is the first in mortality rate of the gynecologic malignancies and the overall 5-year survival rate of ovarian cancer is only 20–30%. Besides, the incidence of ovarian cancer increased in recent years in Taiwan. Ovarian cancer is indeed a disease that should be respected, however, there has only been a little research done focusing on it in Taiwan. Patients with ovarian cancer who have stage I disease (localized to ovaries) after optimal surgical staging do not need any adjuvant therapy. In contrast, patients with disease spreading beyond the ovaries have median survival rates that decrease to < 10% for patients with bulky residual disease after surgery and treated with platinum-based combination chemotherapy. In developing effective therapy for ovarian cancer, there should be a distinction between preventative and therapeutic approaches. Immunoprevention will be developed for women who are at an increased risk for the development of ovarian cancer. In contrast, immunotherapy would be used as an adjuvant to surgery or in combination with chemotherapy or other biologics as chemoimmunotherapy or biochemoimmunotherapy. Mesothelin is expressed in some normal epithelial cells and is elevated in certain carcinomas. Mesothelin has been reported to be selectively overexpressed in most of the non-mucinous ovarian carcinomas. In addition, the specific epitopes of mesothelin in the HLA-A2 and A24 haplotype have been identified. It seems that mesothelin has the potential to be a target antigen for the immunotherapy of ovarian cancer.
So the investigators would like to provide this proposal to address the development of mesothelin -specific immunologic assays. There are two aims in this project:
- to develop and utilize assays to measure cytotoxic T lymphocytes (CTLs) to mesothelin, and
- to evaluate the mesothelin-specific immunologic responses between normal control and ovarian cancer patients.
|Condition or disease|
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|Study Type :||Observational|
|Enrollment :||250 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Study Start Date :||August 2005|
|Study Completion Date :||December 2008|
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): NCT00173394
|Contact: Chi-An Chen, MD||886-2-2312-3456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Chi-An Chen, MD 886-2-2312-3456 ext 5157 firstname.lastname@example.org|
|Principal Investigator:||Chi-An Chen, MD||National Taiwan University Hospital|