Endometrial Cancer: Can We Skip Lymph Node Staging in Some Patients?
Official title: Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
Run by University Hospital Hradec Kralove · NCT07368205 · Data updated 2026-11-12
This study tests whether some women with newly diagnosed endometrial cancer can avoid lymph node staging based on real-world data.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 350 (estimated) |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2031 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07368205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with newly diagnosed endometrial cancer undergoing primary surgery, with preoperative imaging and available tissue for molecular testing.
✕Probably not a fit
Patients who require lymph node staging based on their disease features or who do not fit the identified risk profiles may not benefit from changes in staging recommendations.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study analyzes current risk stratification in endometrial cancer to see if lymph node staging can be tailored or omitted for certain patients. Participants undergo standard care, with no experimental interventions, and are followed for three years after surgery. Data include preoperative imaging, intraoperative sentinel lymph node mapping, and molecular/tissue testing to refine staging recommendations. The goal is to identify which patient groups might not need lymph node staging for proper adjuvant treatment decisions. Outcomes will inform whether existing guidelines can be adapted based on real-world evidence.
Why it matters
Potential benefit: If successful, the findings could reduce unnecessary procedures for some patients while maintaining accurate treatment decisions.
How similar studies have gone: Previous observational research using real-world data has helped refine cancer staging, but this exact approach to tailoring lymph node staging is relatively novel in endometrial cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Hradec Kralove
Hradec Králové, Czechia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.