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Comparing two lab methods to find cancer spread in lymph nodes in endometrial cancer

Tests two lab methods for checking sentinel lymph nodes removed during surgery for endometrial cancer.

Plain-language title generated from the registry record
Registry title: OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer

Key facts

Where
Rome, ItalySee the site

Where in Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people

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Trial details

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Trial code
NCT06935305
Record updated
18 November 2025
Original description
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.Read full original descriptionShow less

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)

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.

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

Exclusion: Fertility sparing surgery; Neoadjuvant therapy; Previous surgery to pelvic lymph nodes; Uterine sarcoma (including endometrial stromal sarcoma); Dedifferentiated histology; Undifferentiated histology; Lymph nodes with short axis >15 mm at pre-operative imaging.

ClinicalTrials.gov NCT06935305