The Canada Lymph Node Score Project: A Crossover Trial

NCT04342377 | Completed Phase 3

• 1 other identifier: clns_10696
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer; Non-small Cell Lung Cancer Stage I; Non-small Cell Lung Cancer Stage II

Keywords

Mediastinal Staging; Nodal Disease; Endobronchial Ultrasound; Diagnostic Testing

Outcome Measures

Primary Outcomes (1)

• Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling

  A margin of 5% or less would be considered satisfactory for STS to be deemed non-inferior to SS.

  2 years

Secondary Outcomes (6)

• 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

Study Arms (2)

Selective Targeted Sampling

EXPERIMENTAL

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

Systematic Sampling

ACTIVE COMPARATOR

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

Interventions

Selective Targeted Sampling DIAGNOSTIC_TEST

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.

Also known as: STS

Selective Targeted Sampling

Systematic Sampling DIAGNOSTIC_TEST

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

Also known as: SS

Systematic Sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Health Sciences Centre, Winnipeg, Manitoba: collaborator
• Royal Alexandra Hospital: collaborator
• Toronto General Hospital: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (7)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

CHUM Endoscopic Tracheo-bronchial and Oesophageal Center

Montreal, Quebec, H2L 4M1, Canada

Location

MUHC Interventional Pulmonology Department

Montreal, Quebec, H4A 3S9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Waël C Hanna, MDCM, MBA, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

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

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: November 30, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)