Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location status: Recruiting

Location contact

Petra Bretova

CONTACT

[email protected]

+420777679238

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

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.

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Acronym: PRSTEC_multipr

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2031
First posted: Jan 26, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting