The Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population

NCT07558889 | Recruiting

• 1 other identifier: 6168
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data

Conditions

Endometrium Cancer; Gynecologic Cancer

Keywords

Molecular classification; Endometrial cancer treatment; Endometrial cancer epidemiology; Endometrial cancer surgical procedures; Minimally invasive surgery; Gynecologic Oncology

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).

  Baseline.

Secondary Outcomes (1)

• Overall Survival

  Baseline.

Study Arms (1)

Endometrial cancer patients

All patients undergoing staging and cytoreduction surgery for endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing staging and cytoreduction surgery for endometrial cancer will be included in the study. This database will make use of data collected retrospectively with prospectively continuously updated prognostic and clinical information. The following data will be collected: clinical characteristics (age, BMI, ASA, previous tumors), histopathological data (histotype, grade, FIGO stage, etc.) Furthermore, data will be collected relating to the adjuvant chemotherapy or radiotherapy treatment performed, survival outcome (DFS and OS), number of relapses and deaths, type of relapse, treatment at relapse, cause of death.

You may qualify if:

• diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes)
• age \> 18 years
• American Society of Anesthesiologists classification (ASA score) 1-3
• patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma
• Signed informed consent

You may not qualify if:

• patients with missing information
• patients not treated in the participating centers for which only partial and fragmented information will be available
• molecular profile not known and\\or not recoverable and retrospectively analysable

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00136, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Francesco Fanfani

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Fanfani, MD

CONTACT

+390630133421; francesco.fanfani@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 30, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2034
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)