Pre-operative risk stratification in apparent early-stage endometrial cancer using expert ultrasound and molecular...

Molecular classification has refined prognostic assessment and adjuvant treatment selection in endometrial cancer, but its role in pre-operative surgical planning remains insufficiently defined. Integrating expert ultrasound, estrogen receptor status, and molecular classification before surgery may improve European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology 2025 risk stratification and support tailored surgical staging in apparent early-stage disease.

To evaluate concordance between integrated pre-operative risk stratification and final post-operative European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology 2025 risk stratification in patients with apparent early-stage endometrial cancer.

Integrated pre-operative risk stratification will accurately predict final post-operative risk stratification and identify patient sub-groups in whom lymph node status is either essential for final post-operative risk classification and adjuvant treatment planning or unlikely to alter management.

This is a prospective multi-center observational study across European gynecologic oncology centers that follow European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology 2025 guidelines in routine treatment practice.

Eligible patients are women aged ≥18 years with newly diagnosed endometrial cancer of any histologic sub-type, apparent stage I to II disease according to the 2023 International Federation of Gynecology and Obstetrics staging system, available expert ultrasound, suitable tumor tissue for histopathologic, immunohistochemical, and molecular assessment, planned primary surgical treatment, and signed informed consent. Key exclusion criteria are neoadjuvant treatment, recurrent or metastatic disease at diagnosis, inadequate imaging or tissue samples, synchronous malignancy, and prior oncologic treatment within 5 years.

The primary end point is concordance between integrated pre-operative risk stratification and final post-operative European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology 2025 risk stratification.

At least 350 patients will be enrolled.

Accrual is expected to be completed in December 2028. Primary end point results are expected after completion of accrual; secondary survival outcomes will be evaluated after 36 months of follow-up.

ClinicalTrials.gov, NCT07368205.