Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

Not Applicable

Not yet recruiting

• Conditions: Non Small Cell Lung Cancer; Circulating Tumor Cell; Lung Cancer
• Interventions: Procedure: Endobronchial ultrasound

• Registration Number: NCT05560776
• Lead Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-29
• Study Start: 2022-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 passes per target on EBUS	Endobronchial ultrasound	-
2 passes per target on EBUS	Endobronchial ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.