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

Condition(s) studied

Investigational drug(s) / intervention(s)

lymph node analysis using the OSNA assay: lymph node analysis using the OSNA assay in early stage NSCLC patients

Study summary

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).

Eligibility

Primary outcome measure(s)

• Number of Participants with nodal micrometastasis with OSNA analisis — through study completion, an average of 5 year
  The primary aim of this prospective study is to assess the effectiveness of the One- Step Nucleic Acid Amplification (OSNA) technique in detecting lymph node micrometastases in patients with clinical stage I-II non-small cell lung cancer (NSCLC) undergoing robotic lung resection. By targeting CK19 mRNA expression, OSNA aims to improve the accuracy of mediastinal lymph node staging.

Trial sites (1)

More Azienda Ospedaliero, Universitaria Pisana trials in Italy

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