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

The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer; Should Preoperative Pathology Samples of Patients Referred to a Tertiary Center be Re-evaluated?

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Endometrial Cancer Stage
• Intervention / Treatment: Diagnostic test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital

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.

• Study Type: Observational
• Enrollment (Actual): 960

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients who received treatment in a tertiary care center for cancer of endometry

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preoperative endometrial sampling result (secondary hospital)/1; Endometrial biopsy samples taken at the stage 2 state hospital	Diagnostic test: 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.
preoperative endometrial sampling result (tertiary hospital)/2; Endometrial biopsy samples taken at the stage (tertiary hospital)	Diagnostic test: 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.
final postoperative pathology/3; final postoperative pathology results with grade (endometrium cancer)	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of endometrial sampling results performed in 2 different centers	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To reveal the rates of under and overdiagnosis of preoperative histological results	Correlation of preoperative pathological diagnoses with postoperative final pathological diagnoses.	1 year

Collaborators and Investigators

• Sponsor: Batman Training and Research Hospital
• Collaborators: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Yusuf Cakmak, M.D, Batman education and research hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2002
• Primary Completion (Actual): April 24, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Endometrial Cancer; preoperative endometrial biopsies; postoperative final pathology
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 2020-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No