The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

NCT00155935 | Unknown

• 1 other identifier: 9261700718
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Cancer

Keywords

ovarian cancer; immunotherapy; folate receptor; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• To develop and utilize assays to measure CTLs to folate receptors

Secondary Outcomes (1)

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

Interventions

venous puncture PROCEDURE

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ovarian cancer patients

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univ. 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

• Wen-Fang Cheng, MD, PhD

  National Taiwan Univ. Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Fang Cheng, MD, PhD

CONTACT

886-2-2312-3456; wenfangcheng@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2004
• Study Completion: December 1, 2008
• Last Updated: August 13, 2007

Record last verified: 2004-01

Locations

TW (1)