Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

Study Overview
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Brief Summary
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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

Official Title
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OPTimizing Endobronchial Ultrasound Sampling In Suspected Non Small Cell Lung Cancer for Molecular Markers : A Pragmatic Randomized Controlled TriaL

Conditions
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Lung Cancer, Non Small Cell Lung Cancer, Circulating Tumor Cell

Intervention / Treatment
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* Procedure: Endobronchial ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 passes per target on EBUS<br> | Procedure: Endobronchial ultrasound<br>* Two or three passes per lymph node<br>|
| Experimental: 3 passes per target on EBUS<br> | Procedure: Endobronchial ultrasound<br>* Two or three passes per lymph node<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node | 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. | At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing | 
| Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy | 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 | At 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/patient | 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. | At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing | 
| Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/sampling scheme | 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. | At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing |