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出境医 / 临床实验 / 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

Study Description
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.

Condition or disease Intervention/treatment
Endometrial Cancer Stage Gynecologic Cancer 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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 960 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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?
Actual Study Start Date : April 12, 2002
Actual Primary Completion Date : April 24, 2021
Actual Study Completion Date : May 27, 2021
Arms 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.

Outcome Measures
Primary Outcome Measures :
  1. Comparison of endometrial sampling results performed in 2 different centers [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. To reveal the rates of under and overdiagnosis of preoperative histological results [ Time Frame: 1 year ]
    Correlation of preoperative pathological diagnoses with postoperative final pathological diagnoses.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients aged 40-90 years diagnosed with endometrial cancer according to endometrial sampling results
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who received treatment in a tertiary care center for cancer of endometry
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
Contacts and Locations

Sponsors and Collaborators
Batman Maternity and Child's Health Hospital
Eskisehir Osmangazi University
Investigators
Layout table for investigator information
Principal Investigator: Yusuf Cakmak, M.D Batman education and research hospital
Tracking Information
First Submitted Date May 27, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date April 12, 2002
Actual Primary Completion Date April 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2021)
Comparison of endometrial sampling results performed in 2 different centers [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 1, 2021)
To reveal the rates of under and overdiagnosis of preoperative histological results [ Time Frame: 1 year ]
Correlation of preoperative pathological diagnoses with postoperative final pathological diagnoses.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer
Official Title 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?
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who received treatment in a tertiary care center for cancer of endometry
Condition
  • Endometrial Cancer Stage
  • Gynecologic Cancer
Intervention 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.
Study Groups/Cohorts
  • preoperative endometrial sampling result (secondary hospital)/1
    Endometrial biopsy samples taken at the stage 2 state hospital
    Intervention: Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital
  • preoperative endometrial sampling result (tertiary hospital)/2
    Endometrial biopsy samples taken at the stage (tertiary hospital)
    Intervention: Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital
  • final postoperative pathology/3
    final postoperative pathology results with grade (endometrium cancer)
    Intervention: Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 1, 2021)
960
Original Actual Enrollment Same as current
Actual Study Completion Date May 27, 2021
Actual Primary Completion Date April 24, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female patients aged 40-90 years diagnosed with endometrial cancer according to endometrial sampling results
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04917341
Other Study ID Numbers 2020-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Erhan Okuyan,M.D, Batman Maternity and Child's Health Hospital
Study Sponsor Batman Maternity and Child's Health Hospital
Collaborators Eskisehir Osmangazi University
Investigators
Principal Investigator: Yusuf Cakmak, M.D Batman education and research hospital
PRS Account Batman Maternity and Child's Health Hospital
Verification Date June 2021