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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Circulating Tumor Cell
• Intervention / Treatment: Procedure: Endobronchial ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Institut universitaire de cardiologie et pneumologie de Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 passes per target on EBUS	Procedure: Endobronchial ultrasound; Two or three passes per lymph node
Experimental: 3 passes per target on EBUS	Procedure: Endobronchial ultrasound; Two or three passes per lymph node

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Investigators: Principal Investigator: Marc Fortin, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating
• Other Study ID Numbers: 2023-3850

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No