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The Canada Lymph Node Score: A Feasibility Randomized Controlled Trial (CLNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859349
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Wael Hanna, St. Joseph's Healthcare Hamilton

Brief Summary:

For patients diagnosed with early stage Non-Small Cell Lung Cancer (NSCLC) on preoperative computerized tomography (CT) and positron emission tomography (PET) scans, surgical resection is usually the preferred method of treatment. However, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. To evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (EBUS) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. Unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. Currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another EBUS, or through more invasive procedures. Repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. To circumvent this issue, the investigators have developed, validated and published a 4-point score, the Canada Lymph Node Score (CLNS), which uses four features observed during EBUS to predict whether the cancer has spread to the lymph nodes or not. Research has demonstrated that lymph nodes which appear benign on both CT and PET scan that also have a CLNS of ≤1/4 are almost certainly benign. As such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy).

The investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. Systematic Sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. Targeted Sampling).To prove this hypothesis, a randomized controlled trial comparing Systematic Sampling to Targeted Sampling is required. A feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Diagnostic Test: Selective Targeted Sampling Diagnostic Test: Systematic Sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants who provide consent for participation and who fulfil eligibility criteria will be randomized with a unique randomization sequence derived from the random permuted block design (with blocks of varying sizes) in a 1:1 ratio. Participants will randomized to either Systematic Sampling (Control) or Targeted Sampling (Experimental).
Masking: Single (Participant)
Masking Description: Trial participants will remain blinded to their randomized treatment. Additionally, the biostatistician performing the analysis will be blinded as to which intervention arm participants were allocated to, as the group allocations will be coded as Group A and Group B. Provided this is an endoscopic trial, endoscopist blinding will not be feasible. Nonetheless, all patients deemed surgical candidates after EBUS will have their pathology compared to EBUS staging in order to ensure appropriate diagnosis. Pathologists performing such pathology report will be blinded to which intervention arm participants are allocated to.
Primary Purpose: Diagnostic
Official Title: Routine Systematic Sampling vs. Targeted Sampling of Mediastinal Lymph Nodes Prior to Lung Cancer Treatment: A Feasibility Randomized Controlled Trial
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : June 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Systematic Sampling
Patients will undergo systematic sampling of lymph node stations in the mediastinum with a minimum sampling of 3 stations: 4R, 4L and 7, as is the standard of care. Other stations may be included at the endoscopist's discretion. CLNS is not used for this arm.
Diagnostic Test: Systematic Sampling
Following routine biopsy of lymph nodes, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines. Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
Other Names:
  • Routine Mediastinal Staging
  • SS

Experimental: Selective Targeted Sampling
Patients will first undergo endosonographic assessment of 3 mediastinal lymph node stations (i.e. 4R, 4L, and 7) using the four criteria of the CLNS. Lymph node stations that exhibit a CLNS >1/4 will be biopsied as is standard of care. Lymph node stations with CLNS ≤ 1/4 will be marked as "not requiring biopsy" but will be biopsied nevertheless, so that there is no deviation from the standard of care. Other stations may be included at the endoscopist's discretion.
Diagnostic Test: Selective Targeted Sampling
After CLNS assessment, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines. Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
Other Names:
  • STS
  • CLNS




Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 1 Year ]
    Minimum acceptable recruitment rate is 70%

  2. Procedure Length [ Time Frame: 1 Day ]
    Calculated in minutes. Recorded for both treatment arms.

  3. Diagnostic Accuracy [ Time Frame: 1 Year ]
    The proportion of patients in whom the treatment (CLNS or biopsy) yielded the same diagnosis as the pathology report out of the total number of patients that have received the treatment. Recorded for both treatment arms.


Secondary Outcome Measures :
  1. Prevalence of Each Possible CLNS [ Time Frame: 1 Year ]
    The CLNS has five possible scores: 0/4, 1/4, 2/4, 3/4 and 4/4. The number of lymph nodes with each score will be recorded for the Experimental Arm (Targeted Sampling).

  2. Frequency of Biopsies [ Time Frame: 1 Year ]
    Number of times lymph nodes had to be sampled with a transbronchial needle per EBUS procedure. Recorded for both treatment arms.

  3. Percent of Inconclusive Biopsies [ Time Frame: 1 Year ]
    Number of biopsies that provided an inconclusive diagnosis out of total number of biopsies obtained. Recorded for each treatment arm.

  4. Adverse Events [ Time Frame: 1 Year ]
    Number of AEs has classified by the Ottawa TM&M System

  5. Accrual Period [ Time Frame: 1 Year ]
    Duration of time to reach sample size



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referred to have EBUS for staging of confirmed or suspected NSCLC
  • Completed both a CT and PET scans
  • cN0-cN1 disease indicated on CT and PET scans

Exclusion Criteria:

  • Patients with cN0 disease, peripheral tumours and tumours < 2 cm in diameter (they do not require staging)
  • Evidence of cN2 disease or higher on CT and PET scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859349


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
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Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC St. Joseph's Healthcare Hamilton / McMaster University
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Responsible Party: Wael Hanna, Head of Endoscopy Services, Thoracic Surgeon, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT03859349    
Other Study ID Numbers: sjhhclns_5829
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wael Hanna, St. Joseph's Healthcare Hamilton:
Endobronchial Ultrasound
Diagnostic Imaging
Feasibility
Randomized Controlled Trial
Clinical N0-N1 Disease
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases