Clinical trial NCT00674349: Screening of Biomarkers on Endometrial Cancers
Official title: Screening and Identification of Novel Diagnostic and Prognostic Biomarkers on Endometrial Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 250
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 ascitogenic itnraperitoneal 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,


Eligibility criteria: Inclusion Criteria:

* Patients with endometrial cancers who undergo hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital. 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.

Primary outcomes:
measure: overall survival
timeFrame: from disease diagnosis to death
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: