Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging (PRSTEC_multipr)

University Hospital Hradec Kralove

Status: Not yet enrolling

Conditions: Endometrial Cancer

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07368205

202511P08

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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