Clinical trial NCT06632431: Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology and Obestetrics (FIGO)
Official title: Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology and Obestetrics (FIGO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinicopathological
Endometrial Carcinoma
Federation of Gynecology and Obestetrics
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in stage
timeFrame: One years after the start of study
Secondary outcomes:
measure: Risk stratification
timeFrame: One years after the start of study
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: