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NCT06935305Recruiting

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)

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1922 (estimated)
First submitted
9 Feb 2025
Start date
30 Jul 2025
Primary completion date
17 Sept 2026
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06935305

What you commit to

  • Study type: Interventional
  • Planned participants: 1922
  • From 30 Jul 2025 to the primary completion date, 17 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Fertility sparing surgery
  • Neoadjuvant therapy
  • Previous surgery to pelvic lymph nodes

Other

  • Uterine sarcoma (including endometrial stromal sarcoma)
  • Dedifferentiated histology
  • Undifferentiated histology
  • Lymph nodes with short axis \>15 mm at pre-operative imaging

Who the study is looking for

  • Histologically confirmed endometrial cancer
  • Apparent (pre-operative) FIGO stage I-II
  • Radical surgery
  • Attempt of SLN mapping

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.