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The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: September 9, 2005
Last updated: August 10, 2007
Last verified: January 2004

Ovarian cancer has the highest mortality rate of gynecologic malignancies and the overall 5-year survival rate of ovarian cancer is only 20-30%. Additionally, the incidence of ovarian cancer has increased in recent years in Taiwan. Ovarian cancer is indeed a disease that should be respected, however, there was very little research work 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 cancer spreading beyond the ovaries have median survival rates that decrease to less than (<) 10% for patients with bulky residual disease after surgery and treatment 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 such as chemoimmunotherapy or biochemoimmunotherapy. The folate receptor (FR) is expressed in some normal epithelial cells and is elevated in certain carcinomas. The FR has been reported to be selectively overexpressed in 90% of non-mucinous ovarian carcinomas. The specific epitopes of the folate receptor in the HLA-A2 haplotype have been identified. It appears that the folate receptor could be a target antigen for the immunotherapy of ovarian cancer.

Therefore the investigators would like to propose the development of folate receptor-specific immunologic assays. There are two aims in this project:

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

Condition Intervention
Ovarian Cancer
Procedure: venous puncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • To develop and utilize assays to measure CTLs to folate receptors

Secondary Outcome Measures:
  • To evaluate the folate receptor-specific immunologic responses between normal controls and ovarian cancer patients

Estimated Enrollment: 50
Study Start Date: January 2004
Estimated Study Completion Date: December 2008
  Show Detailed Description


Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ovarian cancer patients
  Contacts and Locations
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Please refer to this study by its identifier: NCT00155935

Contact: Wen-Fang Cheng, MD, PhD 886-2-2312-3456 ext 5166

National Taiwan Univ. Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Fang Cheng    886-2-2312-3456 ext 5166   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Wen-Fang Cheng, MD, PhD National Taiwan Univ. Hospital
  More Information Identifier: NCT00155935     History of Changes
Other Study ID Numbers: 9261700718
Study First Received: September 9, 2005
Last Updated: August 10, 2007

Keywords provided by National Taiwan University Hospital:
ovarian cancer
folate receptor

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
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 26, 2017