OPTIMAL: Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
Study Details
Study Description
Brief Summary
In this monocentric randomized controlled trial, 120 potential non small cell lung cancer (NSCLC) patients for which tissue diagnosis and material for next generation sequencing (NGS) is required for clinical management will be approached the day of their endobronchial ultrasound to participate in the study. They will be randomized to 2 vs 3 passes/lymph node and will all undergo liquid biopsy. The co-primary outcomes are 1)the rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node and 2)the percentage of patients for which liquid biopsy allows to identify clinically pertinent findings not available from tissue biopsy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2 passes per target on EBUS
|
Procedure: Endobronchial ultrasound
Two or three passes per lymph node
|
| Experimental: 3 passes per target on EBUS
|
Procedure: Endobronchial ultrasound
Two or three passes per lymph node
|
Outcome Measures
Primary Outcome Measures
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node [At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing]
Cell block will be reviewed by a blinded pathologist to determine the percentage of tumor cells within the sample by increment of 5%. More than 10% of tumor cell will be considered adequate.
- Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy [At 1 month]
A case for which liquid biopsy NGS testing allows to identify a genetic alteration not identified by matched tissue biopsy (tissue inadequate, insufficient for molecular testing or adequate but genetic alteration not found) will be considered a case for which liquid biopsy provided additional clinical findings
Secondary Outcome Measures
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/patient [At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing]
Cell block will be reviewed by a blinded pathologist to determine the percentage of tumor cells within the sample by increment of 5%. More than 10% of tumor cell will be considered adequate.
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/sampling scheme [At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing]
Cell block will be reviewed by a blinded pathologist to determine the percentage of tumor cells within the sample by increment of 5%. More than 10% of tumor cell will be considered adequate.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Suspected or confirmed NSCLC requiring tissue sample for NGS testing to guide clinical management
-
Presence of at least 2 targets accessible by EBUS or EUS suspicious of malignancy (primary tumor, lymph node > 10mm or with Standardized Uptake Value (SUV) > 2.5)
Exclusion Criteria:
- Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Investigators
- Principal Investigator: Marc Fortin, Institut Universitaire de Cardiologie et Pneumologie de Quebec
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-3850