Clinical Research Directory

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

Sponsor: Azienda Ulss 2 Marca Trevigiana

Summary

POLE-END is a non-profit, observational, retrospective and prospective study which aims to analyze the clinical course of patients with POLE-mutated endometrial cancer with evaluation of Recurrence-Free Survival (RFS), defined as the interval of time between the diagnosis of POLE-mutated endometrial carcinoma and the diagnosis of disease recurrence (radiological and/or clinical and/or histological diagnosis). In particular, the investigator want to study the influence of the POLE mutation on the survival of patients and therefore on the appearance of relapses by collecting only clinical and anatomopathological-molecular data. The study also has the secondary objective of correlating the clinical outcome with known prognostic factors and with the treatments administered. The data will be collected on a specific Data Collection Form, made anonymous and sent to the promoting center for final analysis. The study will be conducted according to the attached protocol, in compliance with the rules of Good Clinical Practice. The treatment of patients will take place according to normal clinical practice and there are no additional costs borne by the Company and the Regional Health Service. Patient enrollment will take place within the centers belonging to the MITO group that have signed up. Patients will be followed in their respective centers for the duration of their treatments and up to the fifth year after the initial diagnosis of endometrial cancer. The number of patients enrolled for this study will be approximately 80 and will have a maximum overall duration of 9 years. As a non-profit studio, we request exemption from paying research evaluation costs.

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

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