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

Int J Gynecol Cancer. 2023 May 1;33(5):823-826. doi: 10.1136/ijgc-2023-004289.

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.

Keywords: Endometrial Neoplasms; Gynecologic Surgical Procedures.

Publication types

  • Multicenter Study

MeSH terms

  • Endometrial Neoplasms* / pathology
  • Female
  • Genomics
  • Humans
  • Prospective Studies