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Recruiting
NCT05707312
Staging Endometrial caNcer Based on molEcular ClAssification
Conditions: Endometrial Cancer, Lymph Node Metastasis, Sentinel Lymph Node
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 1032
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Location: Spain
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patient was operated during 2021-2022Histological 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 USPreoperative 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 guidelinesA detailed sentinel lymph node study protocol must be accredited, either by ultra-staging or OSNAMolecular 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 womenPrevious hysterectomyPrevious pelvic/para-aortic lymphadenectomyPresence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)Past medical history of any invasive tumorHistory of previous abdominal or pelvic radiotherapy of any type (including braquitherapy)History of preoperative neoadjuvant chemotherapy
Source: ClinicalTrials.gov (NCT05707312). StuddyBuddy aggregates publicly available trial information.