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 | Enrolling By Invitation DMC

• 1 other identifier: 22283
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lung cancer; early-stage NSCLC; robotic surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants with nodal micrometastasis with OSNA analisis

  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.

  through study completion, an average of 5 year

Study Arms (1)

NSCLC patients

patients with no other cancer affected by early stage NSCLC

Diagnostic Test: lymph node analysis using the OSNA assay

Interventions

lymph node analysis using the OSNA assay DIAGNOSTIC_TEST

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

NSCLC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with clinical stage I-II non-small cell lung cancer (NSCLC) undergoing robotic lung resection.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

University of Pisa

Pisa, Pisa, 56125, Italy

Location

Related Publications (4)

• Romano G, Zirafa CC, Calabro F, Ali G, Manca G, De Liperi A, Proietti A, Manfredini B, Di Stefano I, Marciano A, Davini F, Volterrani D, Melfi F. Sentinel Lymph Node Mapping in Lung Cancer: A Pilot Study for the Detection of Micrometastases in Stage I Non-Small Cell Lung Cancer. Tomography. 2024 May 15;10(5):761-772. doi: 10.3390/tomography10050058.

  PMID: 38787018 BACKGROUND

• Nakagawa K, Asamura H, Tsuta K, Nagai K, Yamada E, Ishii G, Mitsudomi T, Ito A, Higashiyama M, Tomita Y, Inoue M, Morii E, Matsuura N, Okumura M. The novel one-step nucleic acid amplification (OSNA) assay for the diagnosis of lymph node metastasis in patients with non-small cell lung cancer (NSCLC): Results of a multicenter prospective study. Lung Cancer. 2016 Jul;97:1-7. doi: 10.1016/j.lungcan.2016.03.015. Epub 2016 Mar 28.

  PMID: 27237020 BACKGROUND

• Masai K, Nakagawa K, Yoshida A, Sakurai H, Watanabe S, Asamura H, Tsuta K. Cytokeratin 19 expression in primary thoracic tumors and lymph node metastases. Lung Cancer. 2014 Dec;86(3):318-23. doi: 10.1016/j.lungcan.2014.09.018. Epub 2014 Oct 12.

  PMID: 25453845 BACKGROUND

• Vodicka J, Mukensnabl P, Vejvodova S, Spidlen V, Kulda V, Topolcan O, Pesta M. A more sensitive detection of micrometastases of NSCLC in lymph nodes using the one-step nucleic acid amplification (OSNA) method. J Surg Oncol. 2018 Feb;117(2):163-170. doi: 10.1002/jso.24826. Epub 2017 Dec 4.

  PMID: 29205350 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 24, 2025
• Study Start: May 17, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IT (1)