The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer

NCT ID: NCT04917341

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 960 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-04-12
• Study Completion Date: 2021-05-27

Brief Summary

Although there are many studies comparing preoperative and postoperative histological diagnoses in the literature, there are no studies evaluating the compatibility of preoperative histological diagnoses obtained from different centers with postoperative histological diagnoses.Therefore, in our study, we aimed to determine whether preoperative pathological specimens need to be re-evaluated in the referenced hospitals by comparing the compatibility of endometrial specimens in secondary care and tertiary centers with their final pathologies.In our study, we aimed to reveal the under and overdiagnosis rates of the preoperative histological diagnoses of our hospitals compared to the final pathology.

Detailed Description

Medical data of 960 patients diagnosed with endometrial cancer by endometrial biopsy between 2002 and 2016 were retrospectively analyzed. Of these patients, 41 were excluded from the study due to non-surgical treatment, 254 patients having biopsy only in one center preoperatively, and lack of medical data in 52 patients.The study included 613 patients who had preoperative endometrial biopsy specimens evaluated by two different centers, diagnosed with endometrial cancer and treated surgically. Our study was conducted in the gynecological oncology department of our university after obtaining the approval of the ethics committee numbered 430-2019.The clinicopathological characteristics of the patients were evaluated by examining the hospital records of age, gravida, parity, BM (body mass index), menopausal status and systemic diseases. Histopathological and clinical features of endometrial cancer were reviewed.In this study, endometrial biopsy samples taken in the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the evaluation process was carried out in two steps by examining the repeated endometrial biopsy sampling.Patients diagnosed with endometrial cancer were treated surgically in our clinic. Endometrial sampling results based on uterine cancer risk groups; While histologically endometrioid and nonendometrioid were evaluated in two groups, the greade1-2 (low risk), greade3 (high risk) of uterine cancer were evaluated in four groups as those without malingnancy (benign and premaling lesions).By comparing these preoperative histological diagnoses with postoperative surgical final pathology, the accuracy rates for histological type and greade were determined. In addition, lower diagnosis, comorbidity and higher diagnosis rates compared to final pathology were examined for two different centers.

Conditions

Endometrial Cancer Stage; Gynecologic Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

preoperative endometrial sampling result (secondary hospital)/1

Endometrial biopsy samples taken at the stage 2 state hospital

re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital

Intervention Type: DIAGNOSTIC_TEST

The endometrial biopsy samples taken at the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the repeated endometrial biopsy sampling was examined and the evaluation process was carried out in two steps.

preoperative endometrial sampling result (tertiary hospital)/2

Endometrial biopsy samples taken at the stage (tertiary hospital)

re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital

Intervention Type: DIAGNOSTIC_TEST

The endometrial biopsy samples taken at the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the repeated endometrial biopsy sampling was examined and the evaluation process was carried out in two steps.

final postoperative pathology/3

final postoperative pathology results with grade (endometrium cancer)

re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital

Intervention Type: DIAGNOSTIC_TEST

The endometrial biopsy samples taken at the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the repeated endometrial biopsy sampling was examined and the evaluation process was carried out in two steps.

Interventions

re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital

The endometrial biopsy samples taken at the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the repeated endometrial biopsy sampling was examined and the evaluation process was carried out in two steps.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Female patients aged 40-90 years diagnosed with endometrial cancer according to

endometrial sampling results

Exclusion Criteria

• Lack of medical data
• Endometrial sampling in only one center

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: collaborator

Batman Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Erhan Okuyan,M.D

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yusuf Cakmak, M.D

Role: PRINCIPAL_INVESTIGATOR

Batman education and research hospital

Other Identifiers

2020-12

Identifier Type: -

Identifier Source: org_study_id