Screening and Identification of Ovarian Cancers

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00854399
Collaborator
(none)
250
1
71
3.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Staging surgery or debulking surgery
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Screening and Identification of Novel Diagnostic and Prognostic Biomarkers on Ovarian Cancers
Study Start Date :
Jan 1, 2006
Anticipated Primary Completion Date :
Jan 1, 2006
Anticipated Study Completion Date :
Dec 1, 2011

Outcome Measures

Primary Outcome Measures

  1. overall survival [from disease diagnosis to death]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 80 Years
Sexes 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

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00854399
Other Study ID Numbers:
  • 200706002R
First Posted:
Mar 3, 2009
Last Update Posted:
Mar 3, 2009
Last Verified:
Mar 1, 2009
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2009