The Assessment of Mesothelin Antigen Specific Immunologic Assays in Ovarian Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Taiwan University Hospital

Brief Summary:

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:

  1. to develop and utilize assays to measure cytotoxic T lymphocytes (CTLs) to mesothelin, and
  2. to evaluate the mesothelin-specific immunologic responses between normal control and ovarian cancer patients.

Condition or disease
Ovarian Cancer

  Show Detailed Description

Study Type : Observational
Enrollment : 250 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Study Start Date : August 2005
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers and ovarian cancer patients will be enrolled from the investigators' department under the approval of the Institutional Review Board.

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 identifier (NCT number): NCT00173394

Contact: Chi-An Chen, MD 886-2-2312-3456 ext 5157

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital Identifier: NCT00173394     History of Changes
Other Study ID Numbers: 9461700630
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 19, 2006
Last Verified: July 2005

Keywords provided by National Taiwan University Hospital:
ovarian cancer
normal volunteer

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