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Epidemiology of Uterine Cancer in Taiwan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01465737
First received: October 26, 2011
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

Endometrial cancer is the second most common gynecologic cancer in Taiwan. Two types of endometrial cancer may be distinguished by standard clinicopathologic criteria; type I tumors are of low grade, endometrioid histology, estrogen related, and have a good prognosis, whereas type II tumors are high grade, of non-endometrioid histologies, unrelated to estrogen, and have a poor prognosis. Several clinicopathological parameters were reported to correlate with prognosis of endometrial cancer including tumor FIGO stage, cell type, cytological grading, depth of myometrial invasion, tumor size, lymph node status, and etc. However, there is no epidemiologic data of endometrial cancer in Taiwan. So the investigators propose this study to use Taiwan registry database provided by Department of Health to analyze the epidemiology and prognosis of uterine cancer patients in Taiwan.


Condition Intervention
Uterine Cancers
Other: Histologic types

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Importance of Cohort and Histologic Type for Secular Trends in Rising Incidence and Different Survival of Uterine Cancer -a Taiwan Population-based Registry From 1979 to 2008

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From diagnosis of uterine cancer to death or last date of linked data available from the Taiwan Cancer Registry or Death Certification Profile ] [ Designated as safety issue: No ]
    The follow-up of each participant (in personyears) was calculated from the date of enrollment to the date of uterine 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.


Estimated Enrollment: 10000
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with uterine cancer
All patients diagnosed with uterine cancer in Taiwan between 1979-2008
Other: Histologic types
evaluate survival among different histologic types
Other Name: Histologic types

Detailed Description:

Study population To evaluate the epidemiology and prognosis of uterine 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 uterine cancer, including uterine carcinoma, uterine sarcoma … etc., will be identified from computerized linkage to the Taiwan national cancer registry with International Classification of Diseases for Oncology Third Edition T-code C540-C543. Histological types will be identified from morphology code in the cancer registry database. Women affected by uterine cancer and found death due to uterine cancer (International Classification of Diseases 9th edition code 182) in deaths certificate will be defined as death cases.

Statistical Analyses The numbers of person-years at risk of developing and dying for uterine cancer will be calculated. Incidence rates will be calculated by dividing the number of uterine cancer cases by the person-years at risk of developing uterine cancer. Mortality rates will be calculated by dividing the number of uterine cancer deaths by the person-years at risk of dying from uterine 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 significant difference statistically when p value is less than 0.05.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All uterine cancer patients in Taiwan between 1979-2008

Criteria

Inclusion Criteria:

  • All uterine cancer patients in Taiwan between 1979-2008

Exclusion Criteria:

  • nil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465737

Contacts
Contact: Wen-Fang Cheng, Professor 886-2-23123456 ext 71964 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Fang Cheng, Professor    886-2-23123456 ext 71964    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Fang Cheng, Professor Department of Obstetrics and Gynecology, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01465737     History of Changes
Other Study ID Numbers: 201103107RC
Study First Received: October 26, 2011
Last Updated: November 2, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
epidemiology
uterine cancer
Taiwan

Additional relevant MeSH terms:
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases

ClinicalTrials.gov processed this record on November 27, 2014