The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

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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

Study Description

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:

to develop and utilize assays to measure cytotoxic T-lymphocytes (CTLs) to folate receptors, and
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

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Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ovarian cancer

MedlinePlus related topics: B Vitamins Folic Acid Ovarian Cancer

Drug Information available for: Folic acid Vitamin B Complex

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

More Information


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

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