High-risk Endometrial CancerNCT04412902
Predictors of Recurrence for High Risk Endometrial Cancer Patients
An observational study of High-risk Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- High-risk Endometrial Cancer
- What is being tested?
- adjuvant therapy
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Apr 2020to 25 Nov 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All high risk endometrial cancer patients
Who may be able to join
- All patients with high risk stage I endometrial cancer and all patients with stage II and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial Hospital from 2009/01/01~2019/09/17.
Who cannot join
- Patients with stage I endometrial cancer do not have high risk factors.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies.
Read the detailed description
The incidence of endometrial cancer is gradually increasing nowaday. The postoperative treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of high-risk endometrial cancer is high.The investigators retrospective study will analyze the factors associated with recurrence of endometrial cancer, especially for different adjuvant therapies.
- Conditions
- High-risk Endometrial Cancer
- Being tested
- adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyDrug
Adjuvant chemotherapy and/or radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting overall survival
Factors affecting overall survival
Measured: 10 years
Secondary outcomes (1)
Factors affecting progression-free survival
Factors affecting progression-free survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start25 Apr 2020
- Primary completion25 Oct 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 92 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
- NCT04412902
- Sponsor's protocol ID
- 109053-E
- Status last verified
- Apr 2020
- First submitted
- 31 May 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Recurrence for High Risk Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT04412902
- Acronym / sponsor ID
- 109053-E
- Conditions
- High-risk Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- 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.
This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies.
Detailed description
The incidence of endometrial cancer is gradually increasing nowaday. The postoperative treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of high-risk endometrial cancer is high.The investigators retrospective study will analyze the factors associated with recurrence of endometrial cancer, especially for different adjuvant therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All high risk endometrial cancer patients
Key inclusion criteria (1 listed)
- All patients with high risk stage I endometrial cancer and all patients with stage II and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial Hospital from 2009/01/01~2019/09/17.
Key exclusion criteria (1 listed)
- Patients with stage I endometrial cancer do not have high risk factors.
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 |
|---|---|---|
| adjuvant therapyAdjuvant chemotherapy and/or radiotherapy | Drug | – |
Primary outcome
Factors affecting overall survival
Time frame: 10 years
Factors affecting overall survival
1 secondary outcome
Factors affecting progression-free survival
Time frame: 10 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 9 Dec 2020.
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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 High-risk 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 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: finished, as of the sponsor's last update on 9 Dec 2020. 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 (time frame: 10 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 9 Dec 2020.