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Lung CancerNCT05596578

Role of Intrapulmonary Lymph Nodes in Patients With NSCLC and Visceral Pleural Invasion

An observational study of Lung Cancer and Lymph Node Metastasis, run by Luzerner Kantonsspital at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Background: Lung cancer is the leading cause of cancer related death worldwide. More than 80% of all lung tumors are Non-Small Cell Lung Cancers (NSCLC). Lymph node staging has a prognostic value and is crucial to establish the optimal treatment strategy in individual patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Lymph Node Metastasis
How many people
958 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2023to 31 Dec 2029
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
  • Adult, Older adult

Study population: Patients recorded prospectively in the database from January 2023 to December 2024 that meet the inclusion and exclusion criteria

Who may be able to join

  • Anatomical resection for NSCLC <3 cm (lobectomy, bilobectomy, segmentectomy)
  • Samples from the intrapulmonary stations 12, 13, and 14 lymph nodes
  • Resection of lymphnodes station 10 and 11 during hilar separation.
  • R0 resection

Who cannot join

  • Prior or synchronous lung cancer
  • pN2
  • Pneumonectomy
  • R1/R2 resection
  • M1
  • Neoadjuvant treatment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabrizio Minervini, MD, PhD contact

+410412051111

fabriziominervini@hotmail.com

Switzerland1 site, 1 recruiting

  • Kantonsspital Luzern

    Lucerne, 6000

    Fabrizio Minervini, MD, PhD, 0764553460, fabriziominervini@hotmail.com

    Recruiting

Other trials in Switzerland

About this study

Background: Lung cancer is the leading cause of cancer related death worldwide. More than 80% of all lung tumors are Non-Small Cell Lung Cancers (NSCLC). Lymph node staging has a prognostic value and is crucial to establish the optimal treatment strategy in individual patients. It remains unknown whether dissecting the intrapulmonary lymph nodes (stations 13 and 14) is necessary for accurate staging and prognostication. Although suggested by several guidelines, these peripheral lymph nodes are not routinely examined in clinical routine for several reasons. Moreover, the prognostic significance of the visceral pleural invasion is controversial. Some studies showed a negative impact on OS and DFS in patients with histologic proved visceral pleura invasion.

The mechanism to explain this negative effect is not fully understood. Given that the visceral pleura is very rich in lymphatic vessels, with an intercommunicating "network" arranged over the lung surface and penetrating into the lung parenchyma to join the bronchial lymph vessels with drainage to the various hilar nodes, we assume that the worse OS and DFS observed in these patients could be explained with the presence of metastatic lymph nodes (Station 13-14) that are not routinely examined. Methods: This is a prospective, multicenter study based on ad-hoc created prospectively database. The incidence of N1 lymph node metastasis overall and the incidence of metastasis to the different lymph node stations (Hilar 10/11, Lobar 12, Sublobar 13/14) will be calculated by dividing the number of the respective events by the patient years separately. To investigate the association between visceral pleural invasion and the presence of metastatic lymph nodes univariate and multivariate logistic regression models will be fitted to the data.

Discussion: The primary outcome is to investigate the incidence of N1 metastases (especially stations 12,13,14) and his relationship with visceral pleural invasion. The secondary outcomes is to evaluate the impact of N1 metastases and/or visceral pleural invasion on long-term outcomes (OS and DFS) along with incidence and pattern of recurrence. DFS is defined as the time of surgical intervention to tumor recurrence or death, and OS is defined as the time of surgical intervention to death

Medical subject headings
Lung Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05596578
Study groupRoleWhat they receive
Group APatients who underwent an anatomical resection for NSCLC <3 cm (lobectomy, bilobectomy, segmentectomy) with samples from the intrapulmonary stations 12, 13, and 14 lymph nodes and resection of lymph nodes station 10 and 11 during hilar separation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. N1

    Overall incidence of N1 pathological lymph nodes (Hilar 10/11, Lobar 12, Sublobar 13/14)

    Measured: January 2023-December 2024

  2. VPI

    Incidence of N1 pathological lymph nodes (Hilar 10/11, Lobar 12, Sublobar 13/14) in patients with pathological evidence of visceral pleural invasion

    Measured: January 2023-December 2024

Secondary outcomes (3)

  1. OS

    Overall Survival (1-3-5 Years)

    Measured: January 2023- December 2029

  2. DFS

    Disease free survival (1-3-5 Years)

    Measured: January 2023-December 2029

  3. Tumor recurrence

    pattern : local, regional, distant

    Measured: January 2023-December 2029

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
958 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05596578
Sponsor's protocol ID
2022.10.Thx
Status last verified
Jan 2023
First submitted
24 Oct 2022
Last updated
9 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang H, Wang T, Hu B, Pan C. Visceral pleural invasion remains a size-independent prognostic factor in stage I non-small cell lung cancer. Ann Thorac Surg. 2015 Apr;99(4):1130-9. doi: 10.1016/j.athoracsur.2014.11.052. Epub 2015 Feb 20.

    PubMed 25704861

  • Bi L, Zhang H, Ge M, Lv Z, Deng Y, Rong T, Liu C. Intrapulmonary lymph node (stations 13 and 14) metastasis in peripheral non-small cell lung cancer. Medicine (Baltimore). 2021 Jul 9;100(27):e26528. doi: 10.1097/MD.0000000000026528.

    PubMed 34232188

  • Seok Y, Lee E. Visceral Pleural Invasion Is a Significant Prognostic Factor in Patients with Partly Solid Lung Adenocarcinoma Sized 30 mm or Smaller. Thorac Cardiovasc Surg. 2018 Mar;66(2):150-155. doi: 10.1055/s-0036-1586757. Epub 2016 Aug 12.

    PubMed 27517168

  • Park S, Cho S, Yum SW, Kim K, Jheon S. Comprehensive analysis of metastatic N1 lymph nodes in completely resected non-small-cell lung cancer. Interact Cardiovasc Thorac Surg. 2015 Nov;21(5):624-9. doi: 10.1093/icvts/ivv209. Epub 2015 Aug 4.

    PubMed 26242319

  • Wightman SC, Lee JY, Ding L, Atay SM, Shemanski KA, McFadden PM, David EA, Kim AW. Adjuvant chemotherapy for visceral pleural invasion in 3-4-cm non-small-cell lung cancer improves survival. Eur J Cardiothorac Surg. 2022 Jun 15;62(1):ezab498. doi: 10.1093/ejcts/ezab498.

    PubMed 35325098

  • Fibla JJ, Cassivi SD, Brunelli A, Decker PA, Allen MS, Darling GE, Landreneau RJ, Putnam JB. Re-evaluation of the prognostic value of visceral pleura invasion in Stage IB non-small cell lung cancer using the prospective multicenter ACOSOG Z0030 trial data set. Lung Cancer. 2012 Dec;78(3):259-62. doi: 10.1016/j.lungcan.2012.09.010. Epub 2012 Oct 3.

    PubMed 23040416

  • Nitadori JI, Colovos C, Kadota K, Sima CS, Sarkaria IS, Rizk NP, Rusch VW, Travis WD, Adusumilli PS. Visceral pleural invasion does not affect recurrence or overall survival among patients with lung adenocarcinoma </= 2 cm: a proposal to reclassify T1 lung adenocarcinoma. Chest. 2013 Nov;144(5):1622-1631. doi: 10.1378/chest.13-0394.

    PubMed 23807749

  • Minervini F, Kestenholz P, Bertoglio P, Li A, Nilius H. Role of intrapulmonary lymph nodes in patients with NSCLC and visceral pleural invasion. The VPI 1314 multicenter registry study protocol. PLoS One. 2023 May 4;18(5):e0285184. doi: 10.1371/journal.pone.0285184. eCollection 2023.

    PubMed 37141291

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Lymph Node Metastasis, run by Luzerner Kantonsspital at 1 site in Switzerland.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Jan 2023. 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 Switzerland. 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?

Contact Fabrizio Minervini, MD, PhD (+410412051111, fabriziominervini@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N1 (time frame: January 2023-December 2024). The study lists 2 primary outcomes in all. 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 NCT05596578, which also lists 8 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 9 Jan 2023.

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