The Canada Lymph Node Score: A Feasibility Randomized Controlled Trial (CLNS)
Routine Systematic Sampling vs. Targeted Sampling of Mediastinal Lymph Nodes Prior to Lung Cancer Treatment: A Feasibility Randomized Controlled Trial
For patients diagnosed with early stage Non-Small Cell Lung Cancer (NSCLC) on preoperative computerized tomography (CT) and positron emission tomography (PET) scans, surgical resection is usually the preferred method of treatment. However, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. To evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (EBUS) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. Unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. Currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another EBUS, or through more invasive procedures. Repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. To circumvent this issue, the investigators have developed, validated and published a 4-point score, the Canada Lymph Node Score (CLNS), which uses four features observed during EBUS to predict whether the cancer has spread to the lymph nodes or not. Research has demonstrated that lymph nodes which appear benign on both CT and PET scan that also have a CLNS of ≤1/4 are almost certainly benign. As such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy).
The investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. Systematic Sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. Targeted Sampling).To prove this hypothesis, a randomized controlled trial comparing Systematic Sampling to Targeted Sampling is required. A feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Referred to have EBUS for staging of confirmed or suspected NSCLC
- Completed both a CT and PET scans
- cN0-cN1 disease indicated on CT and PET scans
Exclusion Criteria:
- Patients with cN0 disease, peripheral tumours and tumours < 2 cm in diameter (they do not require staging)
- Evidence of cN2 disease or higher on CT and PET scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Systematic Sampling
Patients will undergo systematic sampling of lymph node stations in the mediastinum with a minimum sampling of 3 stations: 4R, 4L and 7, as is the standard of care.
Other stations may be included at the endoscopist's discretion.
CLNS is not used for this arm.
|
Following routine biopsy of lymph nodes, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines.
Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
Other Names:
|
|
Experimental: Selective Targeted Sampling
Patients will first undergo endosonographic assessment of 3 mediastinal lymph node stations (i.e.
4R, 4L, and 7) using the four criteria of the CLNS.
Lymph node stations that exhibit a CLNS >1/4 will be biopsied as is standard of care.
Lymph node stations with CLNS ≤ 1/4 will be marked as "not requiring biopsy" but will be biopsied nevertheless, so that there is no deviation from the standard of care.
Other stations may be included at the endoscopist's discretion.
|
After CLNS assessment, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines.
Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: 1 Year
|
Minimum acceptable recruitment rate is 70%
|
1 Year
|
|
Procedure Length
Time Frame: 1 Day
|
Calculated in minutes.
Recorded for both treatment arms.
|
1 Day
|
|
Diagnostic Accuracy
Time Frame: 1 Year
|
The proportion of patients in whom the treatment (CLNS or biopsy) yielded the same diagnosis as the pathology report out of the total number of patients that have received the treatment.
Recorded for both treatment arms.
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Each Possible CLNS
Time Frame: 1 Year
|
The CLNS has five possible scores: 0/4, 1/4, 2/4, 3/4 and 4/4.
The number of lymph nodes with each score will be recorded for the Experimental Arm (Targeted Sampling).
|
1 Year
|
|
Frequency of Biopsies
Time Frame: 1 Year
|
Number of times lymph nodes had to be sampled with a transbronchial needle per EBUS procedure.
Recorded for both treatment arms.
|
1 Year
|
|
Percent of Inconclusive Biopsies
Time Frame: 1 Year
|
Number of biopsies that provided an inconclusive diagnosis out of total number of biopsies obtained.
Recorded for each treatment arm.
|
1 Year
|
|
Adverse Events
Time Frame: 1 Year
|
Number of AEs has classified by the Ottawa TM&M System
|
1 Year
|
|
Accrual Period
Time Frame: 1 Year
|
Duration of time to reach sample size
|
1 Year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC, St. Joseph's Healthcare Hamilton / McMaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sjhhclns_5829
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.