POLE-END REAL LIFE: Endometrial Cancer Early Stages I-II and Advanced Stages III and IV Evaluation of POLE as a Prognostic Factor. Participants Are Women >= 18 Years Old, With the Pole Mutation

NCT06409039ENROLLING_BY_INVITATIONOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Azienda Ulss 2 Marca Trevigiana

Enrollment

80

Start Date

2023-09-04

Completion Date

2024-03-01

Study Type

OBSERVATIONAL

Official Title

STUDIO POLE-END REAL LIFE: Carcinoma Dell'Endometrio Stadi Precoci I-II e Avanzati III e IV Valutazione di POLE Come Fattore Prognostico

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Patients aged \> 18 years;
* Histological diagnosis of POLE-mutated endometrial carcinoma who turned to a center participating in the study starting from 01.01.2020;
* Clinical Diagnosis performed locally at each participating center including histology, immunohistochemistry and molecular evaluation;
* Signing of the informed consent to participate in the study and consent to the processing of personal data.

Exclusion Criteria:

* Patients with endometrial cancer without POLE mutation.
* Patients whose POLE status has been assessed by other methods.

Outcome Measures

Primary Outcomes

POLE-END REAL LIFE STUDY: endometrial cancer early stages I-II and advanced stages III and IV evaluation of POLE as a prognostic factor

Recurrence-Free Survival (RFS) defined as the time interval between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis),The RFS will be calculated with the Kaplan-Meier method and the 3- and 5-year values will be reported with their 95% confidence intervals, Follow-up data will be collected 3 and 5 years after diagnosis of endometrial cancer,the results will be described by means, medians, standard deviations and interquartile ranges if relating to quantitative variables and by absolute and relative frequencies for qualitative variables.

Time frame: 10 years

Locations

Aulss2 Marca Trevigiana Ospedale Ca Foncello, Treviso, Italy

Aulss2 Marca Trevigiana Ospedale Ca Foncello, Treviso, Italy