Epidemiology of Ovarian Cancer in Taiwan

November 2, 2011 updated by: National Taiwan University Hospital
Cancer is the leading cause of mortality in the investigators country. According to the statistics of the Department of Health, the incidence of ovarian cancer increased in recent years and the mortality rate is highest in all gynecologic malignancies in Taiwan. Ovarian cancer becomes a more and more important disease gradually in the field of gynecologic malignancies. The classification of histology in ovarian cancer included epithelial ovarian cancer、germ cell tumors、sex-cord cell tumors…etc. Epithelial ovarian carcinoma is the most common ovarian cancer clinically. Early diagnosis is difficult due to the lack of obvious initial symptoms, so ovarian cancer patients are usually at advanced stage when the diagnosis is confirmed. The prognostic parameters for ovarian carcinomas include tumor stage, histological subtype, degree of malignancy, residual tumor after surgical intervention and the response to chemotherapy. However, the possible etiology and mechanism of ovarian cancer is still unclear. However, there is no epidemiologic data of ovarian cancer in Taiwan. Therefore the investigators propose this study to use Taiwan registry database provided by Department of Health to analyze the epidemiology and prognosis of ovarian cancer patients in Taiwan.

Study Overview

Status

Unknown

Conditions

Detailed Description

Study population: To evaluate the epidemiology and prognosis of ovarian cancer in Taiwan, we will conduct a nationwide analysis through linking national cancer registry database. Every citizen in Taiwan has a life-long identification number to link individual information, including health status. The Taiwan household registry database provided by Department of Health will be the source population. National household registry and death certificate will be adopted to ascertain the live status of study subjects, and provided individual demographic characteristics.All individual linkages between databases will be conducted according to the study protocols, i.e. databases will be linked by corresponding identification number, name (Chinese characters) and birthday, and all data included in this study will be analyzed without individual identification information. The agreement of utilizing the databases in the study was obtained from the Bureau of Health Promotion in Taiwan.

Incident and death cases ascertainment: Patients with ovarian cancer, including epithelial ovarian carcinoma, germ cell tumors, sex cord tumors … etc., will be identified from computerized linkage to the Taiwan national cancer registry with International Classification of Diseases for Oncology Third Edition T-code C569. Histological types will be identified from morphology code in the cancer registry database. Women affected by ovarian cancer and found death due to ovarian cancer (International Classification of Diseases 9th edition code 183) in deaths certificate will be defined as death cases.

Statistical Analyses: The numbers of person-years at risk of developing and dying for ovarian cancer will be calculated. Incidence rates will be calculated by dividing the number of ovarian cancer cases by the person-years at risk of developing ovarian cancer. Mortality rates will be calculated by dividing the number of ovarian cancer deaths by the person-years at risk of dying from ovarian cancer. The association between mortality and age, histology, time periods will be estimated through Kaplan-Meier survival analysis and Cox's proportional hazards model. It is defined as significantly different statistically when p value is less than 0.05.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

ovarian cancer patients

Description

Inclusion Criteria:

Patients of ovarian cancer registered at National Taiwan Cancer registration system between 1979-2008

Exclusion Criteria:

nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ovarian Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From diagnosis of ovarian cancer to death or last date of linked data available from the Taiwan Cancer Registry or Death Certification Profile
The follow-up of each participant (in personyears) was calculated from the date of enrollment to the date of ovarian cancer diagnosis, date of death, or last date of linked data available from the Taiwan Cancer Registry or Death Certification Profile, whichever came first until December 31, 2010.
From diagnosis of ovarian cancer to death or last date of linked data available from the Taiwan Cancer Registry or Death Certification Profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (ESTIMATE)

November 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 2, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201103108RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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