Clinical trial NCT04342377: The Canada Lymph Node Score Project: A Crossover Trial
Official title: Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre, Winnipeg, Manitoba
name: Royal Alexandra Hospital
name: Toronto General Hospital
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2020-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A prospective pan-Canadian, multicentered, non-inferiority crossover study design
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic Statistics (between staging methods)
timeFrame: 2 years
measure: Agreement (between staging methods)
timeFrame: 2 years
measure: Inconclusive Biopsy Rate
timeFrame: 2 years
measure: Diagnostic Yield (accuracy)
timeFrame: 2 years
measure: Difference in Procedure Length
timeFrame: 2 years
measure: Difference in Cost per Procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: CHUM Endoscopic Tracheo-bronchial and Oesophageal Center
state: Quebec
city: Montréal
country: Canada
facility: MUHC Interventional Pulmonology Department
state: Quebec
Study officials:
affiliation: McMaster University
name: Waël C Hanna, MDCM, MBA, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: