Preoperative Risk Stratification in Endometrial Cancer for Tailoring Lymph Node Staging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
Overview
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
- Other No Intervention: Observational Cohort
No intervention
Primary outcome measures
- 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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- University Hospital Hradec Kralove — Hradec Králové
Identifiers
NCT: NCT07368205 · 202511P08