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The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

NCT00155935 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-08-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

venous puncture

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Wen-Fang Cheng, MD, PhD · National Taiwan Univ. Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Completion
2008-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00155935 on ClinicalTrials.gov