Screening and Identification of Ovarian Cancers
Recruitment status was Recruiting
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Purpose
Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease that should be respected, however, there were only few of research work focusing on it in Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction of chemotherapy regimens, the overall survival has changed little over the last two decades. The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this disease and develop new treatment strategies for ovarian cancer in the future.
We have established an ascites-generating intraperitoneal tumor cell line-WF3 in the mouse model in our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with the carcinogenesis, tumor progression and tumor metastasis in our animal model and human cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate the potential of mesothelin as a target antigen for immunotherapy,
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Procedure: Staging surgery or debulking surgery |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Screening and Identification of Novel Diagnostic and Prognostic Biomarkers on Ovarian Cancers |
- overall survival [ Time Frame: from disease diagnosis to death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
-
Procedure: Staging surgery or debulking surgery
Methods:
All of the patients received four to six courses of adjuvant platinum-containing chemotherapy. Histologic grading was according to International Union against Cancer criteria (28). The stage of disease was classified according to the International Federation of Gynecology and Obstetrics (FIGO, 1987). Pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. The histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. The maximal diameter of the residual tumor after surgery will be also recorded. All patients will be followed up at 3-month intervals.
Eligibility| Ages Eligible for Study: | 15 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with ovarian carcinoma who undergo hysterectomy, bilateral oophorectomy and tubal resection, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital.
Exclusion Criteria:
- None
Contacts and Locations| Contact: WEN-FANG CHENG, Associate Professor | 886-2-23123456 | wenfangcheng@yahoo.com |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: WEN-FANG CHENG, ASSOCIATE PROFESSOR 886-2-23123456 wenfangcheng@yahoo.com | |
More Information
No publications provided
| Responsible Party: | Wen-Fang Cheng/Associate Professor, National Taiwan Unviersity Hospital |
| ClinicalTrials.gov Identifier: | NCT00854399 History of Changes |
| Other Study ID Numbers: | 200706002R |
| Study First Received: | April 1, 2008 |
| Last Updated: | March 2, 2009 |
| Health Authority: | Taiwan: Department of Health |
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 |
ClinicalTrials.gov processed this record on May 19, 2013