Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 350
- Primary Endpoint
- The accuracy of preoperative risk stratification
Overview
Brief Summary
The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. The main question it aims to answer is:
Is there any group of patients who doesn't need lymph node staging for proper indication of adjuvant treatment? Participants are note taking any intervention. They are treated according to current standard of care and followed 3-years after primary surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women ≥18 years with newly diagnosed endometrial cancer (any histology)
- •Undergoing primary surgical management
- •Preoperative expert ultrasound, CT scan (could be waived in low risk cases)
- •Preoperatively early-stage (stage I-II) of EC
- •SLN mapping attempted intraoperatively
- •FFPE tumor tissue available for molecular and IHC testing from biopsy
- •Signed informed consent with the participation in the study
Exclusion Criteria
- •Neoadjuvant treatment
- •Recurrent or metastatic disease at diagnosis
- •Inadequate imaging or tissue samples
- •Cancer synchronous duplicity
- •Prior oncological treatment within the last five years
Outcomes
Primary Outcomes
The accuracy of preoperative risk stratification
Time Frame: From enrollment to the first follow-up visit at 4 weeks after surgery.
Determination of specific groups for whom: 1) lymph node staging is crucial for changing risk category and adjuvant treatment decisions, and 2) lymph node staging could be safely omitted
Time Frame: From enrollment to the first follow-up visit at 4 weeks after surgery.
Secondary Outcomes
No secondary outcomes reported