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
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|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- 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 ]
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
|Contact: Chi-An Chen, Professor||886-2-23123456 ext firstname.lastname@example.org|
|Taipei, Taiwan, 100|
|Contact: Yu-Li Chen, M.D 886-2-23123456 ext 5166 email@example.com|
|Contact: Yu-Li Chen, M.D, 886-2-23123456 ext 5166 firstname.lastname@example.org|
|Study Chair:||Chi An Chen, M.D.||Department of Obstetrics and Gynecology, National Taiwan University Hospital|