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.
Improving Endometrial cancer assessment by combining the new techniqUe of GENomic profiling with surgical Extra uterIne disEase assessment (EUGENIE)
Vizzielli G.;
2023-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
