Endometrial Cancer StageNCT04917341
The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer
An observational study of Endometrial Cancer Stage and Gynecologic Cancer, run by Batman Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Endometrial Cancer Stage, Gynecologic Cancer
- What is being tested?
- re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital
- How many people
- 960 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2002to 27 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received treatment in a tertiary care center for cancer of endometry
Who may be able to join
- Female patients aged 40-90 years diagnosed with endometrial cancer according to
- endometrial sampling results
Who cannot join
- Lack of medical data
- Endometrial sampling in only one center
About this study
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?
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.
Read the 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
- Being tested
- re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital
- Keywords
- preoperative endometrial biopsies, postoperative final pathology, Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospitalDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| preoperative endometrial sampling result (secondary hospital)/1 | Endometrial biopsy samples taken at the stage 2 state hospital Receives: 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) Receives: 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) Receives: Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
To reveal the rates of under and overdiagnosis of preoperative histological results
Correlation of preoperative pathological diagnoses with postoperative final pathological diagnoses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start12 Apr 2002
- Primary completion24 Apr 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Cancer StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
- Investigators
- Yusuf Cakmak, M.D, Principal investigator, Batman education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917341
- Sponsor's protocol ID
- 2020-12
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04917341
- Acronym / sponsor ID
- 2020-12
- Conditions
- Endometrial Cancer Stage, Gynecologic Cancer
- Keywords
- preoperative endometrial biopsies, postoperative final pathology, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 12 Apr 2002 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preoperative endometrial sampling result (secondary hospital)/1 | – | Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospitalEndometrial biopsy samples taken at the stage 2 state hospital |
| preoperative endometrial sampling result (tertiary hospital)/2 | – | Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospitalEndometrial biopsy samples taken at the stage (tertiary hospital) |
| final postoperative pathology/3 | – | Diagnostic Test: re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospitalfinal postoperative pathology results with grade (endometrium cancer) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received treatment in a tertiary care center for cancer of endometry
Key inclusion criteria (2 listed)
- Female patients aged 40-90 years diagnosed with endometrial cancer according to
- endometrial sampling results
Key exclusion criteria (2 listed)
- Lack of medical data
- Endometrial sampling in only one center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospitalThe 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. | Diagnostic test | final postoperative pathology/3, preoperative endometrial sampling result (secondary hospital)/1, preoperative endometrial sampling result (tertiary hospital)/2 |
Primary outcome
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.
1 secondary outcome
To reveal the rates of under and overdiagnosis of preoperative histological results
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Cakmak, M.D principal investigator
Batman education and research hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer Stage and Gynecologic Cancer, run by Batman Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of endometrial sampling results performed in 2 different centers (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.