Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology and Obestetrics (FIGO)

October 10, 2024 updated by: yousra hassanin abdelghafour, Assiut University

Assess the percentage change in stage and risk stratification for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.

Investigate the prognostic impact of the FIGO 2023 endometrial staging system on patient survival.

Evaluate how the shift in stage classification between the FIGO 2009 and FIGO 2023 systems influences adjuvant management decisions for endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is the commonest gynecological cancer mostly affecting women in the post-menopausal age group . The average age of women diagnosed with endometrial cancer is 60. It's uncommon in women under the age of 45. The vast majority of endometrial cancers are carcinomas (usually adenocarcinomas). The five-year survival rate for endometrial adenocarcinoma following appropriate treatment is 80%. More than 70% of women diagnosed have Federation of Gynecology and Obestetrics (FIGO) stage I cancer, which has the best prognosis. Stage III and especially Stage IV cancers has a worse prognosis, but these are relatively rare, occurring in only 13% of cases. The median survival time for stage III-IV endometrial cancer is nine to ten months.

The FIGO 2023 staging system provides a refined framework for managing endometrial cancer, benefiting patient care and outcomes as the FIGO 2023 staging system for endometrial cancer offers several advantages over the previous FIGO 2009 system

  1. Improved Prognostic Prediction: The 2023 system predicts survival more accurately, validated by five studies and It adds granularity to prognostic assessment, identifying treatment-relevant subgroups of patients.
  2. Incorporation of Molecular Measures as The 2023 system integrates molecular parameters, reflecting their impact on prognosis (similar to breast cancer staging)
  3. Risk Stratification: It incorporates risk stratification, aiding better prognosis definition and treatment decisions.
  4. Enhanced Understanding of Endometrial Carcinomas: The 2023 system clarifies the diverse biological nature of endometrial cancers, allowing for better-adapted treatment.

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.

Description

Inclusion Criteria:

- Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between January 1, 2018, and December 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks.

Exclusion Criteria:

- Patients who received neoadjuvant chemotherapy, had recurrent endometrial cancer, had multiple cancers, lacked histopathological slides and formalin-fixed paraffin-embedded blocks or lacked medical records were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometrial cancer group
Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy)
Other: Endometrial cancer (EC)

Endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) Histopathological slides for these cases will be reexamined and staged according to both the Federation of Gynecology and Obestetrics (FIGO) 2009 and updated Federation of Gynecology and Obestetrics (FIGO) 2023 endometrial staging systems. Upstaging refers to reclassification to a higher stage in the FIGO 2023 system compared to Federation of Gynecology and Obestetrics (FIGO)2009, while downstaging is the opposite.

All patients underwent lymph node dissection except those with Stage IA-Grades I and II endometrioid endometrial cancer and tumor size <2 cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in stage
Time Frame: One years after the start of study
Percentage change in stage will be recorded for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
One years after the start of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk stratification
Time Frame: One years after the start of study
Risk stratification will be recorded for patients with endometrial cancer when transitioning from the FIGO 2009 endometrial staging system to the updated FIGO 2023 endometrial staging system.
One years after the start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2024-200910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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