RecruitingNot ApplicableNCT06935305

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)

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

1,922 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This trial compares two laboratory methods for detecting cancer spread to lymph nodes in women with endometrial (uterine) cancer who undergo sentinel lymph node mapping during surgery. **You may be eligible if...** - You have been diagnosed with endometrial cancer confirmed by biopsy - Your cancer appears to be stage I or II before surgery - You are having radical (curative) surgery with sentinel lymph node mapping **You may NOT be eligible if...** - You have uterine sarcoma - You are having fertility-sparing surgery - Your cancer is a rare undifferentiated or dedifferentiated type - You received pre-surgery treatment (neoadjuvant therapy) - You have had prior surgery to pelvic lymph nodes - You have large lymph nodes (over 15 mm) visible on pre-surgery imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOSNA

The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method

DEVICEUltrastaging

The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method

Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, Italy

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NCT06935305

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