NCT04917341

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2002

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

19 years

First QC Date

May 27, 2021

Last Update Submit

June 1, 2021

Conditions

Keywords

preoperative endometrial biopsiespostoperative final pathologyEndometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To reveal the rates of under and overdiagnosis of preoperative histological results

    1 year

Study Arms (3)

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

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

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

Interventions

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/3preoperative endometrial sampling result (secondary hospital)/1preoperative endometrial sampling result (tertiary hospital)/2

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients aged 40-90 years diagnosed with endometrial cancer according to endometrial sampling results
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yusuf Cakmak, M.D

    Batman education and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 8, 2021

Study Start

April 12, 2002

Primary Completion

April 24, 2021

Study Completion

May 27, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share