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

Endometrial Carcinoma Clinical Trial

Official title:

Concurrent Endometrial Cancer With Endometrial Hyperplasia or Endometrial Intraepithelial Neoplasia - Focus on Risk Factors Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01273636
• Other study ID #: 200712018R
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2008
• Last updated: January 6, 2011
• Start date: January 2005
• Est. completion date: June 2011

Study information

• Verified date: December 2010
• Source: National Taiwan University Hospital
• Contact: Chi-An Chen, Professor
• Phone: 886-2-23123456
• Email: chianchen[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Locations

Country	Name	City	State
Taiwan	Chi-An Chen	Taipei
Taiwan	Chi-An Chen	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prognosis of patients diagnosed as endometrial carcinoma after hysterectomy.		From carcinoma diagnosed to the last patient follow-up or death till June, 2011	No