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

NCT00173394 | Unknown

• 1 other identifier: 9461700630
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer; immunotherapy; mesothelin; normal volunteer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Chi-An Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-An Chen, MD

CONTACT

886-2-2312-3456; cachen@ha.mc.ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Study Completion: December 1, 2008
• Last Updated: December 19, 2006

Record last verified: 2005-07

Locations

TW (1)