Actively Recruiting

Phase Not Applicable
FEMALE
NCT06935305

OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-11-18

1922

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

S

Sysmex Europe GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed endometrial cancer
  • Apparent (pre-operative) FIGO stage I-II
  • Candidates for radical surgery
  • Planned attempt of sentinel lymph node mapping
Not Eligible

You will not qualify if you...

  • 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 greater than 15 mm on pre-operative imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, Italy, 00168

Actively Recruiting

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Research Team

F

Francesco Fanfani, Professor

CONTACT

N

Nicolò Bizzarri, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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