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
NCT ID: NCT07301983
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
130 participants
OBSERVATIONAL
2023-05-17
2028-12-31
Brief Summary
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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).
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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NSCLC patients
patients with no other cancer affected by early stage NSCLC
lymph node analysis using the OSNA assay
lymph node analysis using the OSNA assay in early stage NSCLC patients
Interventions
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lymph node analysis using the OSNA assay
lymph node analysis using the OSNA assay in early stage NSCLC patients
Eligibility Criteria
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Inclusion Criteria
* Clinical stage I-II
* Absence of pathological lymphadenopathy in preoperative staging (cN0)
Exclusion Criteria
* Prior neoadjuvant chemo-immunotherapy
* Presence of other oncological diseases
* Patient refusal to participate.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero, Universitaria Pisana
OTHER
Responsible Party
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Gaetano Romano
Principal Investigator
Locations
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University of Pisa
Pisa, Pisa, Italy
Countries
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References
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Haustein UF. Pemphigus vulgaris in association with silicosis. Eur J Dermatol. 2000 Dec;10(8):614-6.
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.
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.
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.
Other Identifiers
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22283
Identifier Type: -
Identifier Source: org_study_id