The Canada Lymph Node Score Project: A Crossover Trial

Lung Cancer Clinical Trial

— CLNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342377
• Other study ID #: clns_10696
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	CHUM Endoscopic Tracheo-bronchial and Oesophageal Center	Montréal	Quebec
Canada	MUHC Interventional Pulmonology Department	Montréal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (6)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic Statistics (between staging methods)	Sensitivity, specificity, negative predictive value and positive predictive value	2 years
Secondary	Agreement (between staging methods)	Based on Cohen's Kappa statistics	2 years
Secondary	Inconclusive Biopsy Rate	Percentage of lymph nodes with inconclusive pathology from biopsy	2 years
Secondary	Diagnostic Yield (accuracy)	Proportion of lymph nodes with a pathological diagnosis for both sampling methods	2 years
Secondary	Difference in Procedure Length	For each sampling method (in minutes)	2 years
Secondary	Difference in Cost per Procedure	For each sampling method (sum of dollar costs for EBUS procedure)	2 years