Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The accuracy of preoperative risk stratification
- timeFrame
- From enrollment to the first follow-up visit at 4 weeks after surgery.
- measure
- 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
- timeFrame
- From enrollment to the first follow-up visit at 4 weeks after surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBretova P, Ndukwe MI, Sirak I, Bizzarri N, Fruhauf F, Sukhin V, Laco J, Haviger J, Havigerova JM, Kummel J, Havelka P, Zikan M, Luptakova I, Muzykiewicz K, Novak Z, Cibula D. Pre-operative risk stratification in apparent early-stage endometrial cancer using expert ultrasound and molecular classification: a multi-center prospective observational study (PRSTEC_multipro/CEEGOG EX-07). Int J Gynecol Cancer. 2026 Jul 31:104891. doi: 10.1016/j.ijgc.2026.104891. Online ahead of print. PMID 42629310