Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

NCT05560776 | Active Not Recruiting

• 1 other identifier: 2023-3850
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

2 passes per target on EBUS

EXPERIMENTAL

Procedure: Endobronchial ultrasound

3 passes per target on EBUS

EXPERIMENTAL

Procedure: Endobronchial ultrasound

Interventions

Endobronchial ultrasound PROCEDURE

Two or three passes per lymph node

2 passes per target on EBUS; 3 passes per target on EBUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (1)

Institut Universitaire de Cardiologie et Pneumologie de Quebec

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Fortin

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pathologist will be blinded to study arm when analyzing samples
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 29, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CA (1)