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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: Endometrial cancer patients

Trial outcomes

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).

Time frame
Baseline.

Secondary outcomes

1

Overall Survival

To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of OS (overall survival).

Time frame
Baseline.

Other outcomes

Sponsors and contacts

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