Improving Endometrial cancer assessment by combining the new techniqUe of GENomic profiling with surgical Extra uterIne disEase assessment (EUGENIE)

Abstract

Background The molecular classification of endometrial cancer revolutionized our knowledge of its biology but so far has not affected our surgical approach. The exact risk of extra-uterine metastasis and hence the type of surgical staging for each of the four molecular subgroups are currently unknown. Primary Objective To determine the association between molecular classification and disease stage. Study Hypothesis Each endometrial cancer molecular subgroup has a specific pattern of spread and this pattern of spread could guide the extent of surgical staging. Trial Design Prospective, multicenter study Major Inclusion/Exclusion Criteria Participants eligible for inclusion in this study must meet all the following criteria: women ≥18 years with primary endometrial cancer, any histology and stage. Primary Endpoint Number and site of metastasis in each endometrial cancer molecular subgroup. Sample Size 1000 patients will be enrolled. Estimated Dates for Completing Accrual and Presenting Results The trial will last 6 years: 4 years of accrual, and 2 years of follow-up of all patients. Results on staging and oncological outcomes are expected in 2027 and 2029, respectively. Trial Registration The study has been accepted by UZ Leuven Ethical Committee. Belg. Reg. nr: B3222022000997