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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05707312). StuddyBuddy aggregates publicly available trial information.