The Canada Lymph Node Score Project: A Crossover Trial

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

Interventions

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.

DIAGNOSTIC_TEST

Systematic Sampling

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

Sponsors & Collaborators

• Health Sciences Centre, Winnipeg, Manitoba

  collaborator OTHER

• Royal Alexandra Hospital

  collaborator OTHER

• Toronto General Hospital

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  lead OTHER

Principal Investigators

• Waël C Hanna, MDCM, MBA, FRCSC · McMaster University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• Canada

Study Locations