OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
One Step Nucleic Acid Amplification (OSNA) Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer: a Randomized, Multicenter, Controlled Trial (SENT-OSNA Study)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1,922 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
Summary
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
Eligibility
Inclusion Criteria4
- Histologically confirmed endometrial cancer
- Apparent (pre-operative) FIGO stage I-II
- Radical surgery
- Attempt of SLN mapping
Exclusion Criteria7
- Uterine sarcoma (including endometrial stromal sarcoma)
- Fertility sparing surgery
- Dedifferentiated histology
- Undifferentiated histology
- Neoadjuvant therapy
- Previous surgery to pelvic lymph nodes
- Lymph nodes with short axis \>15 mm at pre-operative imaging
Interventions
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06935305