By invitation only
Evaluation of Lymph Node Analysis Using One Step Nucleic Acid Amplification (OSNA) in Patients With Lung Cancer Who Underwent Robotic Lung Resection, Comparison With Traditional Methods
NCT07301983 · Azienda Ospedaliero, Universitaria Pisana · Updated 24 Dec 2025
- What is being tested
- lymph node analysis using the OSNA assay
- For
- Non Small Cell Lung Cancer
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 130 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 17 May 2023, ends Dec 2028. Registered 24 Dec 2025.
- Results
- None posted yet.
In the researchers' words
This prospective study aims to evaluate the effectiveness of the One-Step Nucleic Acid Amplification (OSNA) technique for detecting micrometastases in lymph nodes of patients with clinical stage I-II non-small cell lung cancer (NSCLC) undergoing robotic lung resection. OSNA targets CK19 mRNA expression in order to improve the accuracy of mediastinal lymph node staging. The secondary objectives are to identify skip metastases, evaluate the potential for pathological upstaging and analyse long-term outcomes such as overall survival (OS) and disease-free survival (DFS). This prospective study was approved by the local Ethics Committee in December 2022, and patient enrolment began in May 2023. The inclusion criteria were: * Resectable non-small cell lung cancer (NSCLC). * Clinical stage I-II. * Absence of pathological lymphadenopathy in preoperative staging (cN0). The exclusion criteria included: * Clinically advanced NSCLC * Neoadjuvant chemo-immunotherapy * Presence of other oncological diseases * Patient refusal to participate. All patients underwent robotic anatomical lung resection combined with systematic lymphadenectomy. Patients were randomised into two groups based on the lymph node (LN) analysis method: OSNA technique or standard histopathological analysis (hematoxylin and eosin or immunohistochemistry).
Sites
- University of PisaPisa, Pisa, Italy
