Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymph node analysis using the OSNA assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NSCLC patients
- description
- patients with no other cancer affected by early stage NSCLC
- interventionNames
- Diagnostic Test: lymph node analysis using the OSNA assay
Primary outcomes (1)
- measure
- Number of Participants with nodal micrometastasis with OSNA analisis
- timeFrame
- through study completion, an average of 5 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDRomano 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
- BACKGROUNDNakagawa 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
- BACKGROUNDMasai 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
- BACKGROUNDVodicka 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