Non Small Cell Lung CancerLALCNCT07301983
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
An observational study of Non Small Cell Lung Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- lymph node analysis using the OSNA assay
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2023to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with clinical stage I-II non-small cell lung cancer (NSCLC) undergoing robotic lung resection.
Who may be able to join
- Resectable non-small cell lung cancer (NSCLC)
- Clinical stage I-II
- Absence of pathological lymphadenopathy in preoperative staging (cN0)
Who cannot join
- Clinically advanced NSCLC
- Prior neoadjuvant chemo-immunotherapy
- Presence of other oncological diseases
- Patient refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the detailed description
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.
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
- Non Small Cell Lung Cancer
- Being tested
- lymph node analysis using the OSNA assay
- Keywords
- lung cancer, early-stage NSCLC, robotic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node analysis using the OSNA assayDiagnostic test
lymph node analysis using the OSNA assay in early stage NSCLC patients
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients | patients with no other cancer affected by early stage NSCLC Receives: Diagnostic Test: lymph node analysis using the OSNA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 May 2023
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Romano, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301983
- Sponsor's protocol ID
- 22283
- Acronym
- LALC
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38787018Nakagawa 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.
PubMed 27237020Masai 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.
PubMed 25453845Vodicka 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.
PubMed 29205350
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07301983
- Acronym / sponsor ID
- LALC / 22283
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, early-stage NSCLC, robotic surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients | – | Diagnostic Test: lymph node analysis using the OSNA assaypatients with no other cancer affected by early stage NSCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with clinical stage I-II non-small cell lung cancer (NSCLC) undergoing robotic lung resection.
Key inclusion criteria (3 listed)
- Resectable non-small cell lung cancer (NSCLC)
- Clinical stage I-II
- Absence of pathological lymphadenopathy in preoperative staging (cN0)
Key exclusion criteria (4 listed)
- Clinically advanced NSCLC
- Prior neoadjuvant chemo-immunotherapy
- Presence of other oncological diseases
- Patient refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymph node analysis using the OSNA assaylymph node analysis using the OSNA assay in early stage NSCLC patients | Diagnostic test | NSCLC patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 38787018Romano 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.
- Background: PubMed 27237020Nakagawa 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.
- Background: PubMed 25453845Masai 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.
- Background: PubMed 29205350Vodicka 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with nodal micrometastasis with OSNA analisis (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07301983, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.