ClinicalTrials.gov
ClinicalTrials.gov Menu

The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00155935
Recruitment Status : Unknown
Verified January 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : August 13, 2007
Sponsor:
Information provided by:
National Taiwan University Hospital

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. 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 or disease Intervention/treatment Phase
Ovarian Cancer Procedure: venous puncture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Development of Human Immunologic Assays Specific to Folate Receptor Antigen
Study Start Date : January 2004
Study Completion Date : December 2008





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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Ovarian cancer patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155935


Contacts
Contact: Wen-Fang Cheng, MD, PhD 886-2-2312-3456 ext 5166 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan Univ. Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Fang Cheng    886-2-2312-3456 ext 5166    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Fang Cheng, MD, PhD National Taiwan Univ. Hospital

ClinicalTrials.gov Identifier: NCT00155935     History of Changes
Other Study ID Numbers: 9261700718
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 13, 2007
Last Verified: January 2004

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

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
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs