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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01560026
First received: June 14, 2011
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Endometrial Cancer
Procedure: surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study for Elevate the Feasibility of Ovarian Preservation With Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    the time of diagnosis to the time of disease recurrence or last follow time


Estimated Enrollment: 300
Study Start Date: August 2000
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ovarian preservation
endometrial cancer with ovarian preservation
Procedure: surgery
endometrial cancer with or without oophorectomy
Other Name: staging surgery with ovarian preservation
oophorectomy
endometrial cancer without ovarian preservation

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 .

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • early stage endometrial cancer after primary surgery exclusion criteria:
  • MMMT, type 2 endometrial cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560026

Contacts
Contact: Yi-Jen Chen, MD 886-2-28757566 chenyj@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, ROC, Taiwan, 11217
Contact: Yi-Jen Chen, PHD    886-2-28757566    chenyj@vghtpe.gov.tw   
Principal Investigator: Yi-Jen Chen, PHD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Study Chair: Yi-Jen Chen Department of Obstetric and Gynecology, Taipei Veterans General Hospital
  More Information

No publications provided

Responsible Party: vghtpe user, Director, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01560026     History of Changes
Other Study ID Numbers: VHG0500
Study First Received: June 14, 2011
Last Updated: March 24, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
ovarian preservation

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014