MedTrace Logo

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 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-12-24

No results posted yet for this 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).

Conditions

  • Non Small Cell Lung Cancer

Interventions

DIAGNOSTIC_TEST

lymph node analysis using the OSNA assay

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

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301983 on ClinicalTrials.gov