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临床试验/NCT00155935
NCT00155935Unknown不适用

The Development of Human Immunologic Assays Specific to Folate Receptor Antigen

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
To develop and utilize assays to measure CTLs to folate receptors

研究概览

简要总结

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.

详细描述

Incidence of Ovarian Cancer

Ovarian cancer is the first mortality rate of gynecologic malignancies with an overall 5-year survival rate of only 20-30%. It became a more and more important disease in recent years and the incidence of ovarian cancer also increased in recent years in Taiwan. The lack of symptoms, difficulties in early diagnosis, insufficient accurate tumor markers, and lack of information about ovarian tumor biology contribute to the poor prognosis in ovarian cancer patients. The prognostic parameters for ovarian carcinomas are tumor stage, histologic subtype, degree of malignancy, and residual tumor after surgical treatment. However, these factors present an incomplete picture of the tumor biology of ovarian cancer and are frequently interrelated. Thus, the identification of new biologic factors predictive of individual disease course and prognosis would be extremely useful. From the above-mentioned data, ovarian cancer is indeed a disease that should be respected, however, there was very little research work focusing on it in Taiwan.

Treatment of ovarian cancer

Epithelial ovarian cancer (EOC) and extraovarian Müllerian carcinoma are similar pathologic entities that share a preference for peritoneal cavity involvement. The spread pattern of these tumors presents a challenge and unique opportunities for immunotherapy. Patients with EOC who have stage I disease (localized to ovaries) after optimal surgical staging, have a 5-year survival rate of 90%, with no significant change at 10 years. In contrast, patients with spreading beyond the ovaries have median survival rates that decrease to < 10% for patients with bulky residual disease after surgery and treatment with platinum-based combination chemotherapy. A randomized trial of first-line chemotherapy in patients with EOC with residual masses larger than 1 cm after initial surgery, showed a median survival period of 38 months for cisplatin/paclitaxel, significantly greater than 24 months for the cisplatin/cytoxan treatment arm. In an interim analysis of an equivalency trial, survival after carboplatin/paclitaxel was not worse than cisplatin/paclitaxel. Even though early diagnosis is an important goal of ongoing clinical research efforts, it is unclear whether advanced EOC starts as a multicentric process involving the ovaries and the peritoneal surface. It is now established that hereditary factors contribute to the development of EOC. Germline BRCA1 and BRCA2 mutations account for approximately 10% of all EOC. In a woman with a BRCA 1 or 2 mutation, lifetime risk for ovarian cancer ranges from 16%-44%. With the commercial availability of genetic testing for BRCA1 and BRCA2, more women are being identified as being at high risk for ovarian cancer. There are no clear guidelines on cancer prevention for these individuals. Although prophylactic oophorectomy is a reasonable option for women who have completed childbearing, these women are still at risk for developing peritoneal cancer. Clearly, other options for prevention are needed.

Immunotherapy for ovarian cancer

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 90 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Ovarian cancer patients

排除标准

  • 未提供

结局指标

主要结局

To develop and utilize assays to measure CTLs to folate receptors

次要结局

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

研究者

申办方类型
Other

研究点 (1)

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