Condition or disease | Intervention/treatment |
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Endometrial Cancer Stage Gynecologic Cancer | Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital |
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 |
Group/Cohort | Intervention/treatment |
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preoperative endometrial sampling result (secondary hospital)/1
Endometrial biopsy samples taken at the stage 2 state hospital
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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)
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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.
|
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 |
Inclusion Criteria:
endometrial sampling results
Exclusion Criteria:
Principal Investigator: | Yusuf Cakmak, M.D | Batman education and research hospital |
Tracking Information | |||||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
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.
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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 |
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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 |
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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.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
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:
endometrial sampling results Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |
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PRS Account | Batman Maternity and Child's Health Hospital | ||||||
Verification Date | June 2021 |