Comparing OSNA and ultrastaging to find sentinel lymph node metastases in endometrial cancer
Official title: 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)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06935305 · Data updated 2026-11-12
This study tests whether the OSNA molecular test finds sentinel lymph node metastases as well as standard ultrastaging in people having surgery for early-stage endometrial cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 1922 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | September 17, 2026 |
| Study ends | March 17, 2029 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06935305 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed endometrial cancer who appear to have FIGO stage I–II disease and are scheduled for radical surgery with an attempt at sentinel lymph node mapping are eligible.
✕Probably not a fit
Patients with uterine sarcoma, dedifferentiated or undifferentiated histologies, prior pelvic nodal surgery, neoadjuvant therapy, very large preoperative lymph nodes, or those not undergoing SLN mapping are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized non-inferiority trial that assigns patients before surgery to either standard histopathologic ultrastaging or the OSNA molecular assay to detect metastases in sentinel lymph nodes. The primary endpoint is the proportion of randomized patients with at least one positive sentinel lymph node, with a planned sample size of 1,922 patients and two interim analyses using an O'Brien–Fleming alpha spending approach. Secondary analyses include classification of isolated tumor cells, micro- and macrometastases and quantification of CK19 mRNA copy number to estimate metastasis volume. Analyses will report proportions with 95% confidence intervals and summarize baseline variables using medians and interquartile ranges.
Why it matters
Potential benefit: If successful, OSNA could provide equally reliable and faster intraoperative detection of sentinel node metastases, potentially reducing the need for additional procedures.
How similar studies have gone: Smaller studies and experience in other cancers suggest OSNA can perform comparably to ultrastaging, but large randomized evidence specifically in endometrial cancer is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, Italy Recruiting
Study contacts
- Principal investigator: Francesco Fanfani, Professor — Fondazione Policlinico Agostino Gemelli IRCCS
- Study coordinator: Francesco Fanfani, Professor
- Email: francesco.fanfani@policlinicogemelli.it
- Phone: +390630153421
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.