The Canada Lymph Node Score Project: A Crossover Trial

Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial

Sponsors

Lead Sponsor: St. Joseph's Healthcare Hamilton

Collaborator: 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

Source St. Joseph's Healthcare Hamilton
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.

Overall Status Recruiting
Start Date 2020-11-30
Completion Date 2022-06-30
Primary Completion Date 2022-06-30
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling 2 years
Secondary Outcome
Measure Time Frame
Diagnostic Statistics (between staging methods) 2 years
Agreement (between staging methods) 2 years
Inconclusive Biopsy Rate 2 years
Diagnostic Yield (accuracy) 2 years
Difference in Procedure Length 2 years
Difference in Cost per Procedure 2 years
Enrollment 80
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Selective Targeted Sampling

Description: 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.

Arm Group Label: Selective Targeted Sampling

Other Name: STS

Intervention Type: Diagnostic Test

Intervention Name: Systematic Sampling

Description: All examined mediastinal lymph nodes are biopsied, regardless of whether they appear normal during PET, CT and EBUS.

Arm Group Label: Systematic Sampling

Other Name: SS

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Waël C Hanna, MDCM, MBA, FRCSC Principal Investigator McMaster University
Overall Contact

Last Name: Waël C Hanna, MDCM, MBA, FRCSC

Phone: (905) 522-1155

Phone Ext.: 35916

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Royal Alexandra Hospital | Edmonton, Alberta, T5H 3V9, Canada Recruiting Simon R Turner, MD, MEd, FRCSC (780) 492-6621 [email protected] Simon R Turner, MD, MEd, FRCSC Principal Investigator
Health Sciences Centre | Winnipeg, Manitoba, R3A 1R9, Canada Not yet recruiting Biniam Kidane, MD, MSc, FRCSC (204) 787-3109 [email protected] Biniam Kidane, MD, MSc, FRCSC Principal Investigator
St. Joseph's Healthcare Hamilton | Hamilton, Ontario, L8N 4A6, Canada Recruiting Waël C Hanna, MDCM, MBA, FRCSC (905) 522-1155 35916 [email protected] Waël C Hanna, MDCM, MBA, FRCSC Principal Investigator
McMaster University | Hamilton, Ontario, L8S 4L8, Canada Recruiting Waël C Hanna, MDCM, MBA, FRCSC (905) 522-1155 35916 [email protected] Waël C Hanna, MDCM, MBA, FRCSC Principal Investigator
Toronto General Hospital | Toronto, Ontario, M5G 2C4, Canada Recruiting Kazuhiro Yasufuku, MD, PhD, FCCP (416) 340-4729 [email protected] Kazuhiro Yasufuku, MD, PhD, FCCP Principal Investigator
CHUM Endoscopic Tracheo-bronchial and Oesophageal Center | Montréal, Quebec, H2L 4M1, Canada Recruiting Moishe Liberman, MD, PhD, FACS, FRCSC (514) 890-8000 26832 [email protected] Moishe Liberman, MD, PhD, FACS, FRCSC Principal Investigator
MUHC Interventional Pulmonology Department | Montréal, Quebec, H4A 3S9, Canada Recruiting Anne Gonzalez, MD, MSc (514) 934-1934 32117 [email protected] Anne Gonzalez, MD, MSc Principal Investigator
Location Countries

Canada

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: McMaster University

Investigator Full Name: Wael Hanna

Investigator Title: Lead Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Selective Targeted Sampling

Type: Experimental

Description: 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.

Label: Systematic Sampling

Type: Active Comparator

Description: 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.

Acronym CLNS
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: A prospective pan-Canadian, multicentered, non-inferiority crossover study design

Primary Purpose: Diagnostic

Masking: None (Open Label)

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