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

NCT ID: NCT01273636

Last Updated: 2011-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

National Taiwan Unviersity Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chi An Chen, M.D.

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology, National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chi-An Chen

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Chi-An Chen

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chi-An Chen, Professor

Role: CONTACT

886-2-23123456 ext. 5166

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yu-Li Chen, M.D

Role: primary

886-2-23123456 ext. 5166

Yu-Li Chen, M.D,

Role: primary

886-2-23123456 ext. 5166

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200712018R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.