Endometrial CancerNCT01886040
Factors Affecting the Prognosis of Patients With Endometrial Cancer
An observational study of Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to May 2016
- 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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: the cases with endometrial cancer
Who may be able to join
- Time interval: from 1991 to date.
- Comprehensive surgical staging or debulking procedure.
- All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.
Who cannot join
- Not comprehensive staging/debulking procedure.
- Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I \& II, the most histology is still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.
Most patients has good outcome of endometrial cancer because their surgical stage is belonged to "early stage". However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.
Read more
Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential "sandwich" therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.
The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases with endometrial cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting overall survival and disease-free survival of endometrial cancer
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886040
- Sponsor's protocol ID
- 102058-E
- Status last verified
- Feb 2016
- First submitted
- 21 Jun 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Prognosis of Patients With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01886040
- Acronym / sponsor ID
- 102058-E
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jun 2013 (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 common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I \& II, the most histology is still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.
Most patients has good outcome of endometrial cancer because their surgical stage is belonged to "early stage". However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.
Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential "sandwich" therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.
The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases with endometrial cancer | – | – |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the cases with endometrial cancer
Key inclusion criteria (3 listed)
- Time interval: from 1991 to date.
- Comprehensive surgical staging or debulking procedure.
- All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.
Key exclusion criteria (2 listed)
- Not comprehensive staging/debulking procedure.
- Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors affecting overall survival and disease-free survival of endometrial cancer
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrial Cancer, run by Far Eastern Memorial 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors affecting overall survival and disease-free survival of endometrial cancer (time frame: 20 years). 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 Sep 2016.