Evaluation of One Step Nucleic Acid Amplification for Detection of Lymph Node Metastases in Endometrial Cancer

Endometrial cancer (EC) is the most common gynecological cancer worldwide, with its incidence rising due to factors like increased life span and obesity. The study focuses on the importance of lymph node status in determining therapeutic outcomes and introduces the sentinel lymph node biopsy (SLNB) as a less invasive alternative to systematic lymphadenectomy for nodal evaluation.

The research explores the use of OSNA, a rapid molecular test, for the analysis of sentinel lymph nodes (SLNs) in EC patients. OSNA has been previously used in breast, gastric, and colorectal cancers and is now being tested in gynecological cancers. The study aims to compare the diagnostic accuracy of OSNA with the current gold standard, ultrastaging, in detecting lymph node metastases.

This prospective, multicenter study involves at least 300 eligible patients and focuses on the diagnostic performance of OSNA in a routine clinical setting. The primary endpoint is the analysis at the lymph node level, assessing sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the overall concordance rate between OSNA and ultrastaging.

The study also considers the potential of OSNA to influence patient care, including adjuvant treatment and disease-free survival (DFS). The research protocol has been approved by the institutional review board and ethical committee, ensuring compliance with Good Clinical Practice (GCP) and the Helsinki Declaration.

OSNA's introduction into clinical practice could standardize and make detailed sentinel node examination more accessible in endometrial cancer. The study's recruitment began in autumn 2020 and continues, aiming to raise awareness of OSNA as a valid diagnostic test and encourage other centers to participate.