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Lung CancerPhase 3CLNSNCT04342377

The Canada Lymph Node Score Project: A Crossover Trial

A Phase 3 study testing Selective Targeted Sampling and Systematic Sampling in people with Lung Cancer and Non Small Cell Lung Cancer, run by St. Joseph's Healthcare Hamilton at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Before deciding on treatment for patients with lung cancer, a critical step in the investigation is finding out whether the lymph nodes in the chest contain cancer cells. This is accomplished with a biopsy of the lymph nodes through the airway wall, known as Endobronchial Ultrasound-guided Transbronchial Needle… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Selective Targeted Sampling and Systematic Sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
7 sitesCanada
Study dates
30 Nov 2020to 30 Jun 2022
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Age ≥ 18 years
  • Both CT and PET scans completed prior to EBUS
  • Suspected or confirmed NSCLC requiring mediastinal staging
  • cN0-cN1 as indicated by CT and PET scans

Who cannot join

  • Patients with cN0 disease AND peripheral tumors AND tumor < 2 cm in diameter, as they do not require mediastinal staging
  • Evidence of cN2 disease or higher on CT and PET scans

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • McMaster University

    Hamilton, Ontario, L8S 4L8

  • CHUM Endoscopic Tracheo-bronchial and Oesophageal Center

    Montreal, Quebec, H2L 4M1

  • MUHC Interventional Pulmonology Department

    Montreal, Quebec, H4A 3S9

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial

Before deciding on treatment for patients with lung cancer, a critical step in the investigation is finding out whether the lymph nodes in the chest contain cancer cells. This is accomplished with a biopsy of the lymph nodes through the airway wall, known as Endobronchial Ultrasound-guided Transbronchial Needle Aspiration. Guidelines require that every single lymph node in the chest be biopsied through a process called Systematic Sampling. However, emerging data suggests that the lymph nodes that appear benign on imaging and ultrasound do not need a biopsy. A proposed alternative to the inefficient Systematic Sampling is the simplified Selective Targeted Sampling of the lymph nodes, whereby only lymph nodes that look malignant are biopsied. This trial will evaluate the simplified Selective Targeted Sampling of lymph nodes and compare it to Systematic Sampling to see whether it is equally as effective in staging lung cancer.

Read the detailed description

Treatment decisions in Non-Small Lung Cancer (NSCLC) are reliant on a thorough staging process that includes imaging with Computed Tomography (CT), Positron Emission Tomography (PET) and Systematic Sampling (SS) of mediastinal lymph nodes (LNs) by Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA). Collectively, the results of these staging procedures dictate whether patients will be treated with surgery, radiation and/or chemotherapy. Current guidelines for SS through EBUS-TBNA mandate the biopsy of at least 3 mediastinal LN stations (4R, 4L and 7) in the chest, even if they appear normal on CT and PET scan. Despite improvements in diagnostic techniques and safety, LN biopsies remain onerous for the patient and costly to our healthcare system. SS is also unreliable, yielding inconclusive pathology results in 42.14% of cases, especially for Triple Normal LNs, which are LNs that appear normal on PET, and CT, and EBUS. In fact, SS results in mostly negative or inconclusive biopsies for Triple Normal LNs, which may be due in part to their very low probability (< 6%) of malignancy. As such, the researchers have proposed to replace the onerous and unreliable process of SS by a simpler Selective Targeted Sampling (STS) staging process. In STS, Triple Normal LNs will not be biopsied, due to the very high negative predictive value (NPV) of malignancy. STS follows the simple notion that only LNs that have the potential to be malignant should be biopsied, whereas LNs which are very likely benign (i.e. Triple Normal LNs) should not be biopsied.

Being tested
Selective Targeted Sampling, Systematic Sampling
Keywords
Mediastinal Staging, Nodal Disease, Endobronchial Ultrasound, Diagnostic Testing
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Selective Targeted SamplingDiagnostic test

    Also called STS

    Mediastinal lymph nodes are assessed with the CLNS, and only those appearing malignant with the score are biopsied. Triple Normal lymph nodes (normal appearing on PET, CT and EBUS) are not biopsied.

  • Systematic SamplingDiagnostic test

    Also called SS

    All examined mediastinal lymph nodes are biopsied, regardless of whether they appear normal during PET, CT and EBUS.

Study groups in NCT04342377
Study groupRoleWhat they receive
Selective Targeted SamplingExperimentalDuring patients' Endobronchial Ultrasound (EBUS) procedure, they will first undergo: Selective Targeted Sampling - endosonographic assessment of at least 3 mediastinal lymph node stations (4R, 4L, and 7) using the four criteria of the Canada Lymph Node Score (predictor of nodal disease during Endobronchial Ultrasound). Each lymph node will be assigned a CLNS ranging from 0 to 4. Triple Normal lymph nodes will be defined as those that appear normal on CT (diameter < 1 cm), AND normal on PET (SUV < 2.5), AND normal on EBUS (CLNS < 2). Lymph nodes that are found to be Triple Normal will be marked as "Not for Biopsy", whereas all other lymph nodes will be biopsied.
Receives: Diagnostic Test: Selective Targeted Sampling
Systematic SamplingActive comparatorUpon completion of Systematic Targeted Sampling, all patients will crossover and receive the standard of care: Systematic Sampling - all lymph nodes previously marked as "Not for Biopsy" will be biopsied. At the conclusion of the EBUS procedure, all nodal stations would have been sampled as is mandated by current guidelines.
Receives: Diagnostic Test: Systematic Sampling

What is being measured

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

  1. Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling

    A margin of 5% or less would be considered satisfactory for STS to be deemed non-inferior to SS.

    Measured: 2 years

Secondary outcomes (6)

  1. Diagnostic Statistics (between staging methods)

    Sensitivity, specificity, negative predictive value and positive predictive value

    Measured: 2 years

  2. Agreement (between staging methods)

    Based on Cohen's Kappa statistics

    Measured: 2 years

  3. Inconclusive Biopsy Rate

    Percentage of lymph nodes with inconclusive pathology from biopsy

    Measured: 2 years

  4. Diagnostic Yield (accuracy)

    Proportion of lymph nodes with a pathological diagnosis for both sampling methods

    Measured: 2 years

  5. Difference in Procedure Length

    For each sampling method (in minutes)

    Measured: 2 years

  6. Difference in Cost per Procedure

    For each sampling method (sum of dollar costs for EBUS procedure)

    Measured: 2 years

Timeline

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

  1. First posted13 Apr 2020
  2. Study start30 Nov 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Model description
A prospective pan-Canadian, multicentered, non-inferiority crossover study design
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342377
Sponsor's protocol ID
clns_10696
Acronym
CLNS
Status last verified
Jul 2022
First submitted
8 Apr 2020
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sullivan KA, Farrokhyar F, Patel YS, Liberman M, Turner SR, Gonzalez AV, Nayak R, Yasufuku K, Hanna WC. Preoperative mediastinal staging in early-stage lung cancer: Targeted nodal sampling is not inferior to systematic nodal sampling. J Thorac Cardiovasc Surg. 2024 Aug;168(2):391-398. doi: 10.1016/j.jtcvs.2023.11.020. Epub 2023 Nov 21.

    PubMed 37981101

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selective Targeted Sampling and Systematic Sampling in people with Lung Cancer and Non Small Cell Lung Cancer, run by St. Joseph's Healthcare Hamilton at 7 sites in Canada.

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 2 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling (time frame: 2 years). 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 NCT04342377, which also lists 1 linked publication.

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 27 Jul 2022.

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The Canada Lymph Node Score Project: A Crossover Trial | AzTrials