Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma (ECWOP)

March 24, 2012 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • ROC
      • Taipei, ROC, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Yi-Jen Chen, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • early stage endometrial cancer after primary surgery exclusion criteria:
  • MMMT, type 2 endometrial cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ovarian preservation
endometrial cancer with ovarian preservation
Procedure: surgery
endometrial cancer with or without oophorectomy
Other Names:
  • staging surgery with ovarian preservation
oophorectomy
endometrial cancer without ovarian preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
disease recurrence or last follow time, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Chair: Yi-Jen Chen, Department of Obstetric and Gynecology, Taipei Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 24, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHG0500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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