Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-05-01

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

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Detailed Description

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Conditions

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Lung Cancer Non Small Cell Lung Cancer Circulating Tumor Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Pathologist will be blinded to study arm when analyzing samples

Study Groups

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2 passes per target on EBUS

Group Type EXPERIMENTAL

Endobronchial ultrasound

Intervention Type PROCEDURE

Two or three passes per lymph node

3 passes per target on EBUS

Group Type EXPERIMENTAL

Endobronchial ultrasound

Intervention Type PROCEDURE

Two or three passes per lymph node

Interventions

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Endobronchial ultrasound

Two or three passes per lymph node

Intervention Type PROCEDURE

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)