The Canada Lymph Node Score Project: A Crossover Trial (CLNS)
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| ClinicalTrials.gov Identifier: NCT04342377 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2020
Last Update Posted : March 22, 2021
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Sponsor:
St. Joseph's Healthcare Hamilton
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
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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 |
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 : | 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
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 :
- 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 :
- 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)
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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
| 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
| 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
| Principal Investigator: | Waël C Hanna, MDCM, MBA, FRCSC | McMaster University |
| 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 |
| 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:
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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 |