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Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment
Sponsor: University Hospital, Gasthuisberg
Summary
EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis.
Official title: Improving Endometrial Cancer Assessment by Combining the New techniqUe of GENomic Profiling With Surgical Extra uterIne disEase Assessment
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2023-01-16
Completion Date
2028-11-01
Last Updated
2024-04-17
Healthy Volunteers
No
Conditions
Interventions
total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging
Surgical treatment will consist of total hysterectomy with bilateral salpingo-oophorectomy according to international guidelines. In low- and intermediate-risk EC patients, staging will include a sentinel lymph node (SLN) procedure. In high intermediate-risk and high-risk EC patients, lymph node staging will involve SLN procedure and/or pelvic and para-aortic lymph node dissection (LND), depending on the local protocol. The Study-related procedures include infracolic omentectomy or two separate omental representative biopsies, biopsies of all suspicious lesions as well as six peritoneal sites (bladder, pouch of Douglas, bilateral paracolic gutter and bilateral diaphragm). Stage IV patients will be treated according to European guidelines. When feasible, full surgical intervention (i.e. debulking) is recommended. If this cannot be achieved, a radiologic and/or histologic confirmation of tumor spread beyond the uterus will be accepted.
Locations (1)
UZ Gasthuisberg, Katholieke Universiteit Leuven
Leuven, Belgium