Clinical trial · Observational
Staging Endometrial caNcer Based on molEcular ClAssification
NCT05707312CI-TRIAL-00063574unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 SENECA study tries to evaluate the rate of lymph node involvement depending on the molecular subgroup in early-stage endometrial cancer (I/II) patients undergoing surgery as part of their treatment.
Conditions
Conditions (3)
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 |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- POLEmut (POLE mutant endometrial cancer patients)
- description
- POLE mutant endometrial cancer patients
- label
- MMRd (mismatch repair deficient endometrial cancer patients)
- description
- mismatch repair deficient endometrial cancer patients
- label
- NSMP (no specific molecular profile endometrial cancer patients to NSMP)
- description
- no specific molecular profile endometrial cancer patients to NSMP
- label
- p53abn (p53 abnormal endometrial cancer patients)
- description
- p53 abnormal endometrial cancer patients
Primary outcomes (1)
- measure
- Sentinel lymph node involvement rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient was operated during 2021-2022 * Histological confirmation of Endometrial Cancer with endometrioid histology or high risk histology (serous, clear cell, carcinosarcoma and mixed histologies) * Preoperative FIGO stage I or II by MRI or US * Preoperative CT-Scan or PET-CT without evidence of local or distant disease (could be omitted in low-risk and intermediate risk endometrial carcinoma with low grade histology) * Surgical protocol according to ESGO/ESTRO/ESP guidelines * A detailed sentinel lymph node study protocol must be accredited, either by ultra-staging or OSNA * Molecular analysis performed on the pathology specimen according to ESGO/ESTRO/ESP guidelines (POLE mutation analysis could be omitted in low-risk and intermediate risk endometrial carcinoma with low grade histology). Exclusion Criteria: * Pregnant women * Previous hysterectomy * Previous pelvic/para-aortic lymphadenectomy * Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis) * Past medical history of any invasive tumor * History of previous abdominal or pelvic radiotherapy of any type (including braquitherapy) * History of preoperative neoadjuvant chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.