Clinical trial · Interventional
The Canada Lymph Node Score Project: A Crossover Trial
Improving Preoperative Lung Cancer Staging Through the Canada Lymph Node Project: A Pan-Canadian Multicentered Crossover Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective Targeted Sampling | Diagnostic Test | — | UNRESOLVED |
| Systematic Sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Selective Targeted Sampling
- description
- 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.
- interventionNames
- Diagnostic Test: Selective Targeted Sampling
- type
- ACTIVE_COMPARATOR
- label
- Systematic Sampling
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSullivan KA, Farrokhyar F, Patel YS, Liberman M, Turner SR, Gonzalez AV, Nayak R, Yasufuku K, Hanna WC. Preoperative mediastinal staging in early-stage lung cancer: Targeted nodal sampling is not inferior to systematic nodal sampling. J Thorac Cardiovasc Surg. 2024 Aug;168(2):391-398. doi: 10.1016/j.jtcvs.2023.11.020. Epub 2023 Nov 21. PMID 37981101