Screening and Identification of Ovarian Cancers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854399
First received: April 1, 2008
Last updated: March 2, 2009
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Procedure: Staging surgery or debulking surgery
    Staging surgery or debulking surgery
Detailed Description:

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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854399

Contacts
Contact: WEN-FANG CHENG, Associate Professor 886-2-23123456 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: WEN-FANG CHENG, ASSOCIATE PROFESSOR    886-2-23123456    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
  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 July 24, 2014