The Canada Lymph Node Score Project: A Crossover 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: NCT04342377|
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : July 27, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A prospective pan-Canadian, multicentered, non-inferiority crossover study design|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||June 30, 2022|
|Actual Study Completion Date :||June 30, 2022|
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
- 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.
- 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)
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
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Hamilton, Ontario, Canada, L8S 4L8|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|CHUM Endoscopic Tracheo-bronchial and Oesophageal Center|
|Montréal, Quebec, Canada, H2L 4M1|
|MUHC Interventional Pulmonology Department|
|Montréal, Quebec, Canada, H4A 3S9|
|Principal Investigator:||Waël C Hanna, MDCM, MBA, FRCSC||McMaster University|