Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC (OPTIMAL)

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Status: Active, not recruiting

Conditions: Lung Cancer; Circulating Tumor Cell; Non Small Cell Lung Cancer

Treatments: Procedure: Endobronchial ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05560776

2023-3850

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

2 passes per target on EBUS

Experimental group

Treatment:

Procedure: Endobronchial ultrasound

3 passes per target on EBUS

Experimental group

Treatment:

Procedure: Endobronchial ultrasound