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

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ClinicalTrials.gov Identifier: NCT04342377
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : July 27, 2022
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

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date July 27, 2022
Actual Study Start Date  ICMJE November 30, 2020
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • Diagnostic Statistics (between staging methods) [ Time Frame: 2 years ]
    Sensitivity, specificity, negative predictive value and positive predictive value
  • Agreement (between staging methods) [ Time Frame: 2 years ]
    Based on Cohen's Kappa statistics
  • Inconclusive Biopsy Rate [ Time Frame: 2 years ]
    Percentage of lymph nodes with inconclusive pathology from biopsy
  • Diagnostic Yield (accuracy) [ Time Frame: 2 years ]
    Proportion of lymph nodes with a pathological diagnosis for both sampling methods
  • Difference in Procedure Length [ Time Frame: 2 years ]
    For each sampling method (in minutes)
  • Difference in Cost per Procedure [ Time Frame: 2 years ]
    For each sampling method (sum of dollar costs for EBUS procedure)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Canada Lymph Node Score Project: A Crossover Trial
Official Title  ICMJE Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Intervention: Diagnostic Test: Selective Targeted Sampling
  • 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.

    Intervention: Diagnostic Test: Systematic Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04342377
Other Study ID Numbers  ICMJE clns_10696
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Wael Hanna, McMaster University
Original Responsible Party Wael Hanna, St. Joseph's Healthcare Hamilton, Lead Investigator
Current Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC McMaster University
PRS Account St. Joseph's Healthcare Hamilton
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP