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NCT Number: NCT06935305

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Location status: Recruiting

Location contact

Francesco Fanfani

CONTACT

[email protected]

+39 0630153421

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OSNA

Device

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

Ultrastaging

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Fanfani, Professor

CONTACT

[email protected]

+390630153421

Nicolò Bizzarri, Dr

CONTACT

[email protected]

+393471771680

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Sysmex Europe GmbH

Registry information

Official study title

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)

Acronym: SENT-OSNA

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Apr 20, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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