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

NCT ID: NCT06632431

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinicopathological Endometrial Carcinoma Federation of Gynecology and Obestetrics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endometrial cancer group

Patients diagnosed with endometrial cancer (EC) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy)

Endometrial cancer (EC)

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yousra hassanin abdelghafour

Demonstrator of Pathology, Faculty of Medicine , Assiut University, Assiut, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yousra H Abdelghafour, MBBCH

Role: CONTACT

00201149264064

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yousra H Abdelghafour, MBBCH

Role: primary

00201149264064

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04-2024-200910

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.