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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173394
First received: September 12, 2005
Last updated: December 18, 2006
Last verified: July 2005
  Purpose

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
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 250
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers and ovarian cancer patients will be enrolled from the investigators' department under the approval of the Institutional Review Board.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00173394

Contacts
Contact: Chi-An Chen, MD 886-2-2312-3456 ext 5157 cachen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157    cachen@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173394     History of Changes
Other Study ID Numbers: 9461700630
Study First Received: September 12, 2005
Last Updated: December 18, 2006
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014