Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging

Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07368205

Acronym

PRSTEC_multipr

Enrollment

350

Registered

2026-01-26

Start date

2026-02-15

Completion date

2031-02-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial cancer, molecular classification, expert ultrasonography, lymph node staging

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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The accuracy of preoperative risk stratification	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	From enrollment to the first follow-up visit at 4 weeks after surgery.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026