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

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, 56125, Italy

About this study

Cytokeratin 19 is a cytoskeletal component exclusively found in normal or neoplastic epithelial cells, and its presence in lymph nodes serves as an indicator of involvement by tumor cells of epithelial origin.The OSNA method represents a novel approach that determines the number of mRNA copies in the homogenized entire lymph node, overcoming the limitations of hematoxylin- eosin and immunohistochemistry methods that only analyze histological sections and avoiding sampling bias due to the non-uniform localization of metastatic foci. The present study aims to evaluate the advantages of using molecular lymph node assessment in homogeneous samples of patients with the same clinical stage of tumour presentation, stage I and II N0 NSCLC, to optimise data comparison and reduce the risk of potential bias.

Secondary objectives will be the identification of skip metastases and lymph node upstaging.

The future perspective of the study is to analyse long-term follow-up data through outpatient surveillance and radiological examinations to estimate possible disease recurrence and mortality rates in patients 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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Resectable non-small cell lung cancer (NSCLC)
Clinical stage I-II
Absence of pathological lymphadenopathy in preoperative staging (cN0)

Exclusion criteria

Clinically advanced NSCLC
Prior neoadjuvant chemo-immunotherapy
Presence of other oncological diseases
Patient refusal to participate.

Treatment and study plan

lymph node analysis using the OSNA assay

Diagnostic Test

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

Primary outcomes

Number of Participants with nodal micrometastasis with OSNA analisis

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Acronym: LALC

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Dec 24, 2025
Registry last updated: Dec 24, 2025

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

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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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