Status:
RECRUITING
OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Sysmex Europe GmbH
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
Phase:
NA
Brief 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 me...
Detailed Description
This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ult...
Eligibility Criteria
Inclusion
- Histologically confirmed endometrial cancer
- Apparent (pre-operative) FIGO stage I-II
- Radical surgery
- Attempt of SLN mapping
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2029
Estimated Enrollment :
1922 Patients enrolled
Trial Details
Trial ID
NCT06935305
Start Date
July 30 2025
End Date
March 17 2029
Last Update
November 18 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, Italy, 00168