Uterine CancersNCT01465737
Epidemiology of Uterine Cancer in Taiwan
An observational study of Uterine Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Cancers
- What is being tested?
- Histologic types
- How many people
- 10,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All uterine cancer patients in Taiwan between 1979-2008
Who may be able to join
- All uterine cancer patients in Taiwan between 1979-2008
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wen-Fang Cheng, Professor, 886-2-23123456 ext. 71964, wenfangcheng@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Uterine Cancers
- Being tested
- Histologic types
- Keywords
- epidemiology, uterine cancer, Taiwan
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histologic typesOther
evaluate survival among different histologic types
| Study group | Role | What they receive |
|---|---|---|
| Patients with uterine cancer | All patients diagnosed with uterine cancer in Taiwan between 1979-2008 Receives: Other: Histologic types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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.
Measured: From diagnosis of uterine cancer to death or last date of linked data available from the Taiwan Cancer Registry or Death Certification Profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Fang Cheng, Professor, Principal investigator, Department of Obstetrics and Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465737
- Sponsor's protocol ID
- 201103107RC
- Status last verified
- Nov 2011
- First submitted
- 26 Oct 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01465737
- Acronym / sponsor ID
- 201103107RC
- Conditions
- Uterine Cancers
- Keywords
- epidemiology, uterine cancer, Taiwan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with uterine cancer | – | Other: Histologic typesAll patients diagnosed with uterine cancer in Taiwan between 1979-2008 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All uterine cancer patients in Taiwan between 1979-2008
Key inclusion criteria (1 listed)
- All uterine cancer patients in Taiwan between 1979-2008
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histologic typesevaluate survival among different histologic types | Other | Patients with uterine cancer |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Fang Cheng, Professor principal investigator
Department of Obstetrics and Gynecology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cancers, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Fang Cheng, Professor (886-2-23123456 ext. 71964, wenfangcheng@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.