OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer (SENT-OSNA)

November 15, 2025 updated by: Fanfani Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ultrastaging has an average value of 11%. Assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. Two interim analyses are planned, one after the first 640 and the second after 1280 patients. At the first interim analysis null hypothesis (inferiority of OSNA with respect to ultrastaging) will be rejected at a significance level <0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. The final analysis will use 0.0189 as significance threshold. The O'Brien Fleming alpha spending function was used to define these values.

The primary endpoint is defined as the proportion of patients with positive SLN over the total of randomized patients. This proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. Incidence of isolated tumor cells, micro- and macro-metastasis will be calculated.

Number of copies of CK19 mRNA to define volume of metastases will be adapted from previous reports.

To describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. Patients will be described according the arm they were randomized to. A first analysis will be performed on an Intent-To-Treat basis, considering all randomized patients. A secondary analysis will be performed on the Per-Protocol population.

Study Type

Interventional

Enrollment (Estimated)

1922

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrastaging arm
In this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard)
Device: Ultrastaging
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method
Experimental: OSNA arm
In this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental)
Device: OSNA
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SLN metastasis detected by OSNA versus ultrastaging method
Time Frame: From enrollment to the acquisition of the histological examination (8 weeks)
We will evaluate the number of lymph node metastases identified with both methods, in order to calculate the incidence of lymph node metastases for each group
From enrollment to the acquisition of the histological examination (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
Time Frame: 3 years (a 3-year follow-up is planned)
The aim is to assess the impact of both techniques on staging, prognosis, and therapeutic strategies, optimizing patient management according to molecular subtypes.
3 years (a 3-year follow-up is planned)
Disease-free survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
Time Frame: 3 years (a 3-year follow-up is planned)
The aim is to assess the impact of both techniques on staging, prognosis, and therapeutic strategies, optimizing patient management according to molecular subtypes.
3 years (a 3-year follow-up is planned)
3 year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
Time Frame: 3 years (a 3-year follow-up is planned)
The study evaluates 3 year disease-free survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
3 years (a 3-year follow-up is planned)
3 year overall survival (measured in months) in OSNA versus ultrastaging negative patients
Time Frame: 3 years (a 3-year follow-up is planned)
The study evaluates 3 year overall survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
3 years (a 3-year follow-up is planned)
5-year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
Time Frame: 5 years
The study evaluates 5-year disease-free survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
5 years
5-year overall survival (measured in months) in OSNA versus ultrastaging negative patients
Time Frame: 5 years
The study evaluates 5-year overall survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
5 years
Incidence of endosalpingiosis in ultrastaging arm
Time Frame: From enrollment to the acquisition of the histological examination (8 weeks)
The study investigates the incidence of endosalpingiosis in the ultrastaging arm of sentinel lymph node analysis in endometrial carcinoma. The aim is to assess its frequency, potential clinical significance, and implications for pathological interpretation and patient management.
From enrollment to the acquisition of the histological examination (8 weeks)
Total Tumor Load (calculating by summing the number of copies of CK19 from each sentinel lymph node) and correlation with prognosis
Time Frame: 3 years (a 3-year follow-up is planned)
The study examines the total tumor load (TTL), defined as the sum of CK19 copies from each sentinel lymph node (SLN), and its correlation with prognosis.
3 years (a 3-year follow-up is planned)
Dimension of SLN (measured in millimeters) metastases at ultrastaging and correlation with prognosis
Time Frame: 3 years (a 3-year follow-up is planned)
The study analyzes the size of sentinel lymph node (SLN) metastases detected through ultrastaging and its correlation with prognosis in endometrial carcinoma. The objective is to evaluate the prognostic significance of metastasis dimensions and their potential impact on clinical management and treatment decisions.
3 years (a 3-year follow-up is planned)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Sysmex Europe GmbH

Investigators

  • Principal Investigator: Francesco Fanfani, Professor, Fondazione Policlinico Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

September 17, 2026

Study Completion (Estimated)

March 17, 2029

Study Registration Dates

First Submitted

February 9, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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