NCT01560026

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

11.3 years

First QC Date

June 14, 2011

Last Update Submit

March 24, 2012

Conditions

Keywords

ovarian preservation

Outcome Measures

Primary Outcomes (1)

  • 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

    disease recurrence or last follow time, up to one year

Study Arms (2)

ovarian preservation

endometrial cancer with ovarian preservation

Procedure: surgery

oophorectomy

endometrial cancer without ovarian preservation

Interventions

surgeryPROCEDURE

endometrial cancer with or without oophorectomy

Also known as: staging surgery with ovarian preservation
ovarian preservation

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • MMMT, type 2 endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, ROC, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yi-Jen Chen

    Department of Obstetric and Gynecology, Taipei Veterans General Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 14, 2011

First Posted

March 21, 2012

Study Start

August 1, 2000

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations