Endometrial CancerECWOPNCT01560026
Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma
An observational study of Endometrial Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Endometrial cancer is one of the most common female malignancies in the United States, and has increased in incidence in Taiwan in recent decades.A recent population-based analysis noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore it is up to 15% in Taiwan according to the… Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2000to Dec 2012
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators retrospectively reviewed the cases of 150 patients who had primary surgery with early stage endometrial cancer between January 1989 and December 2009
Who may be able to join
- early stage endometrial cancer after primary surgery exclusion criteria:
- MMMT, type 2 endometrial cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, ROC, 11217
Yi-Jen Chen, PHD, 886-2-28757566, chenyj@vghtpe.gov.tw
Yi-Jen Chen, PHD
About this study
Official title: Study for Elevate the Feasibility of Ovarian Preservation With Endometrial Carcinoma
Endometrial cancer is one of the most common female malignancies in the United States, and has increased in incidence in Taiwan in recent decades.A recent population-based analysis noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment of endometrial cancer results in surgical menopause and places patients at risk for the long-term sequelae of estrogen deprivation. The goal of this study was to determine the frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian preservation in women with treatment for endometrial cancer.
Read the detailed description
we reviewed the cases with early stage of endometrial cancer who have primary staging surgery between January 1989 to December 2009. The enrolled patients will be divided into two group (oophorectomy vs. ovary preservation) for analysis:the outcome and recurrence type.To evaluate the outcome of ovarian preservation in women with endometrial cancer .
- Conditions
- Endometrial Cancer
- Being tested
- surgery
- Keywords
- ovarian preservation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Also called staging surgery with ovarian preservation
endometrial cancer with or without oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| ovarian preservation | endometrial cancer with ovarian preservation Receives: Procedure: surgery | |
| oophorectomy | endometrial cancer without ovarian preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
from the time of diagnosis to the time of disease recurrence or last follow time
the time of diagnosis to the time of disease recurrence or last follow time
Measured: disease recurrence or last follow time, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startAug 2000
- Primary completionDec 2011
- Study completionDec 2012 (estimated)
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.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Yi-Jen Chen, Study chair, Department of Obstetric and Gynecology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560026
- Sponsor's protocol ID
- VHG0500
- Acronym
- ECWOP
- Status last verified
- Mar 2012
- First submitted
- 14 Jun 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Elevate the Feasibility of Ovarian Preservation With Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT01560026
- Acronym / sponsor ID
- ECWOP / VHG0500
- Conditions
- Endometrial Cancer
- Keywords
- ovarian preservation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Aug 2000
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Mar 2012 (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 one of the most common female malignancies in the United States, and has increased in incidence in Taiwan in recent decades.A recent population-based analysis noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment of endometrial cancer results in surgical menopause and places patients at risk for the long-term sequelae of estrogen deprivation. The goal of this study was to determine the frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian preservation in women with treatment for endometrial cancer.
Detailed description
we reviewed the cases with early stage of endometrial cancer who have primary staging surgery between January 1989 to December 2009. The enrolled patients will be divided into two group (oophorectomy vs. ovary preservation) for analysis:the outcome and recurrence type.To evaluate the outcome of ovarian preservation in women with endometrial cancer .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian preservation | – | Procedure: surgeryendometrial cancer with ovarian preservation |
| oophorectomy | – | –endometrial cancer without ovarian preservation |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators retrospectively reviewed the cases of 150 patients who had primary surgery with early stage endometrial cancer between January 1989 and December 2009
Key inclusion criteria (2 listed)
- early stage endometrial cancer after primary surgery exclusion criteria:
- MMMT, type 2 endometrial cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| surgeryAlso: staging surgery with ovarian preservationendometrial cancer with or without oophorectomy | Procedure or surgery | ovarian preservation |
Primary outcome
from the time of diagnosis to the time of disease recurrence or last follow time
Time frame: disease recurrence or last follow time, up to one year
the time of diagnosis to the time of disease recurrence or last follow time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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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.
Yi-Jen Chen study chair
Department of Obstetric and Gynecology, Taipei Veterans General 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 Endometrial Cancer, run by Taipei Veterans General Hospital, Taiwan 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 2 inclusion and 0 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 27 Mar 2012. 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 Yi-Jen Chen, MD (886-2-28757566, chenyj@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
from the time of diagnosis to the time of disease recurrence or last follow time (time frame: disease recurrence or last follow time, up to one year). 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 27 Mar 2012.