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

May 18, 2026 updated by: University Hospital Hradec Kralove

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia
        • Recruiting
        • University hospital Hradec Králové
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with histologicaly confirmed endometrial cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202511P08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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