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Risk Factors for Concurrent Endometrial Carcinoma in Patients With a Curettage Diagnosis of Endometrial Hyperplasia

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ClinicalTrials.gov Identifier: NCT01273636
Recruitment Status : Unknown
Verified December 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease
Endometrial Carcinoma

Detailed Description:

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 by D&C (dilation and curettage) in all patients. Twenty of them were diagnosed as having endometrial carcinoma in their hysterectomy specimens. All of the specimens were reviewed by a gynecologic pathologist.

Depending on the final pathologic reports of hysterectomy, we divided the seventy-seven patients into two groups - the non-endometrial carcinoma group and the endometrial carcinoma group. Fifty-seven of the studied patients were in the non-endometrial carcinoma group and twenty were in the endometrial carcinoma group. As already mentioned above, we investigated them by clinical parameters including age, menopausal status, obstetrical history, medical history of diabetes and hypertension, BMI (body mass index) and preoperative pathology of D&C.

The clinical and pathologic characteristics of the twenty patients diagnosed as having endometrial carcinoma postoperatively were also reviewed. Initial manifestation, histological grading of the carcinoma, the depth of myometrial invasion, with or without adjuvant radiotherapy and recurrence were included. The histological grading of endometrial carcinoma was based on FIGO ( International Federation of Gynecology and Obstetrics ) definitions. The BMIs of the patients with endometrial carcinoma were also analyzed by the receiver operating characteristic curve. The Research and Ethics Committee of National Taiwan University Hospital approved this study.

Statistical analyses were performed with the Independent-Samples T test and the Mann-Whitney test. Subsequently, multivariate analysis of risk factors was also employed with Binary logistic regression model to obtain the adjusted odds ratio (OR) and 95% confidence interval (CI) for selective variables. P<0.05 was defined as significant.


Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Concurrent Endometrial Cancer With Endometrial Hyperplasia or Endometrial Intraepithelial Neoplasia - Focus on Risk Factors Analysis
Study Start Date : January 2005
Estimated Primary Completion Date : January 2006
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. The prognosis of patients diagnosed as endometrial carcinoma after hysterectomy. [ Time Frame: From carcinoma diagnosed to the last patient follow-up or death till June, 2011 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273636


Contacts
Contact: Chi-An Chen, Professor 886-2-23123456 ext 5166 chianchen@ntu.edu.tw

Locations
Taiwan
Chi-An Chen Recruiting
Taipei, Taiwan, 100
Contact: Yu-Li Chen, M.D    886-2-23123456 ext 5166    uly1007@yahoo.com.tw   
Chi-An Chen Recruiting
Taipei, Taiwan
Contact: Yu-Li Chen, M.D,    886-2-23123456 ext 5166    uly1007@yahoo.com.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Chi An Chen, M.D. Department of Obstetrics and Gynecology, National Taiwan University Hospital
More Information

Responsible Party: Chi-An Chen/Professor, National Taiwan Unviersity Hospital
ClinicalTrials.gov Identifier: NCT01273636     History of Changes
Other Study ID Numbers: 200712018R
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: December 2010

Keywords provided by National Taiwan University Hospital:
Endometrial hyperplasia
Hysterectomy
Endometrial carcinoma

Additional relevant MeSH terms:
Carcinoma
Hyperplasia
Endometrial Neoplasms
Endometrial Hyperplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female