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The Canada Lymph Node Score Project: A Crossover Trial (CLNS)

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ClinicalTrials.gov Identifier: NCT04342377
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : March 22, 2021
Sponsor:
Collaborators:
Health Sciences Centre, Winnipeg, Manitoba
Royal Alexandra Hospital
Toronto General Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Information provided by (Responsible Party):
Wael Hanna, McMaster University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Non Small Cell Lung Cancer Non-small Cell Lung Cancer Stage I Non-small Cell Lung Cancer Stage II Diagnostic Test: Selective Targeted Sampling Diagnostic Test: Systematic Sampling Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A prospective pan-Canadian, multicentered, non-inferiority crossover study design
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selective Targeted Sampling

During 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.

Diagnostic Test: Selective Targeted Sampling
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.
Other Name: STS

Active Comparator: Systematic Sampling

Upon 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.

Diagnostic Test: Systematic Sampling
All examined mediastinal lymph nodes are biopsied, regardless of whether they appear normal during PET, CT and EBUS.
Other Name: SS




Primary Outcome Measures :
  1. Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling [ Time Frame: 2 years ]
    A margin of 5% or less would be considered satisfactory for STS to be deemed non-inferior to SS.


Secondary Outcome Measures :
  1. Diagnostic Statistics (between staging methods) [ Time Frame: 2 years ]
    Sensitivity, specificity, negative predictive value and positive predictive value

  2. Agreement (between staging methods) [ Time Frame: 2 years ]
    Based on Cohen's Kappa statistics

  3. Inconclusive Biopsy Rate [ Time Frame: 2 years ]
    Percentage of lymph nodes with inconclusive pathology from biopsy

  4. Diagnostic Yield (accuracy) [ Time Frame: 2 years ]
    Proportion of lymph nodes with a pathological diagnosis for both sampling methods

  5. Difference in Procedure Length [ Time Frame: 2 years ]
    For each sampling method (in minutes)

  6. Difference in Cost per Procedure [ Time Frame: 2 years ]
    For each sampling method (sum of dollar costs for EBUS procedure)



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:

  • 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

Exclusion Criteria:

  • 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

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): NCT04342377


Contacts
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Contact: Waël C Hanna, MDCM, MBA, FRCSC (905) 522-1155 ext 35916 hannaw@mcmaster.ca
Contact: Yogita Patel, BSc (905) 522-1155 ext 35096 patelys@mcmaster.ca

Locations
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Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Simon R Turner, MD, MEd, FRCSC    (780) 492-6621    sturner@ualberta.ca   
Principal Investigator: Simon R Turner, MD, MEd, FRCSC         
Canada, Manitoba
Health Sciences Centre Not yet recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Biniam Kidane, MD, MSc, FRCSC    (204) 787-3109    bkidane@hsc.mb.ca   
Principal Investigator: Biniam Kidane, MD, MSc, FRCSC         
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Waël C Hanna, MDCM, MBA, FRCSC    (905) 522-1155 ext 35916    hannaw@mcmaster.ca   
Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC         
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Waël C Hanna, MDCM, MBA, FRCSC    (905) 522-1155 ext 35916    hannaw@mcmaster.ca   
Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Kazuhiro Yasufuku, MD, PhD, FCCP    (416) 340-4729    kazuhiro.yasufuku@uhn.ca   
Principal Investigator: Kazuhiro Yasufuku, MD, PhD, FCCP         
Canada, Quebec
CHUM Endoscopic Tracheo-bronchial and Oesophageal Center Recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Moishe Liberman, MD, PhD, FACS, FRCSC    (514) 890-8000 ext 26832    moishe.liberman@umontreal.ca   
Principal Investigator: Moishe Liberman, MD, PhD, FACS, FRCSC         
MUHC Interventional Pulmonology Department Recruiting
Montréal, Quebec, Canada, H4A 3S9
Contact: Anne Gonzalez, MD, MSc    (514) 934-1934 ext 32117    anne.gonzalez@mcgill.ca   
Principal Investigator: Anne Gonzalez, MD, MSc         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Health Sciences Centre, Winnipeg, Manitoba
Royal Alexandra Hospital
Toronto General Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC McMaster University
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Responsible Party: Wael Hanna, Lead Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT04342377    
Other Study ID Numbers: clns_10696
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, McMaster University:
Mediastinal Staging
Nodal Disease
Endobronchial Ultrasound
Diagnostic Testing
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms