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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Development of Human Immunologic Assays Specific to Folate Receptor Antigen|
|Study Start Date :||January 2004|
|Study Completion Date :||December 2008|
U.S. FDA Resources
- To develop and utilize assays to measure CTLs to folate receptors
- To evaluate the folate receptor-specific immunologic responses between normal controls and ovarian cancer patients
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
|Contact: Wen-Fang Cheng, MD, PhD||886-2-2312-3456 ext firstname.lastname@example.org|
|National Taiwan Univ. Hospital||Recruiting|
|Contact: Wen-Fang Cheng 886-2-2312-3456 ext 5166 email@example.com|
|Principal Investigator:||Wen-Fang Cheng, MD, PhD||National Taiwan Univ. Hospital|