Article Text
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
- Endometrial Neoplasms
- Gynecologic Surgical Procedures
Data availability statement
Data are available upon request.
Statistics from Altmetric.com
Data availability statement
Data are available upon request.
Footnotes
Twitter @Ritarella_
JCK and RT contributed equally.
Contributors JCK and RT contributed equally to this paper. JCK, JP, FA: conceptualization; JCK, RT, FA: protocol development and manuscript writing; AL: statistical analysis; JP, TB, A-SVR, IZ, GV, JK, FF: critical analysis, final editing; FA: guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.