NCT01273636

Brief Summary

Objective: To examine the risk factors for coexisting endometrial carcinoma in patients with endometrial hyperplasia. Method: Seventy-seven patients who received hysterectomy for endometrial hyperplasia were enrolled and divided into the non-endometrial carcinoma group (57) and the endometrial carcinoma group (20) depending on the final pathology. Clinical variables were analyzed.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 10, 2011

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

August 14, 2008

Last Update Submit

January 6, 2011

Conditions

Endometrial Carcinoma

Keywords

Endometrial hyperplasiaHysterectomyEndometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • The prognosis of patients diagnosed as endometrial carcinoma after hysterectomy.

    From carcinoma diagnosed to the last patient follow-up or death till June, 2011

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We retrospectively reviewed the cases of seventy-seven patients who had hysterectomies for endometrial hyperplasia between January 1996 and September 2006 at the Department of Obstetrics and Gynecology, National Taiwan University Hospital. A preoperative pathologic diagnosis of endometrial hyperplasia was obtained in all patients.

You may qualify if:

  • Endometrial hyperplasia patient having hysterectomy with or without bilateral salpingo-oophorectomy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chi-An Chen

Taipei, Taiwan, 100, Taiwan

RECRUITING

Chi-An Chen

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsEndometrial Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chi An Chen, M.D.

    Department of Obstetrics and Gynecology, National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Chi-An Chen, Professor

CONTACT

886-2-23123456chianchen@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2008

First Posted

January 10, 2011

Study Start

January 1, 2005

Primary Completion

January 1, 2006

Study Completion

June 1, 2011

Last Updated

January 10, 2011

Record last verified: 2010-12

Locations

TW(2)