NCT06935305 OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
| NCT ID | NCT06935305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,922 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,922 participants in total. It began in 2025-07-30 with a primary completion date of 2026-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 method (standard), while in the other arm it will be conducted using the OSNA method.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed endometrial cancer * Apparent (pre-operative) FIGO stage I-II * Radical surgery * Attempt of SLN mapping Exclusion Criteria: * 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
Contact & Investigator
Francesco Fanfani, Professor
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06935305 clinical trial?
This trial is open to female participants only, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06935305 currently recruiting?
Yes, NCT06935305 is actively recruiting participants. Contact the research team at francesco.fanfani@policlinicogemelli.it for enrollment information.
Where is the NCT06935305 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06935305 clinical trial?
NCT06935305 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Francesco Fanfani, Professor at Fondazione Policlinico Agostino Gemelli IRCCS. The trial plans to enroll 1,922 participants.
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