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NCT05560776 | Not yet recruiting | Lung Cancer


Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
Sponsor:

University Institute of Cardiology and Pneumology of Quebec, University Laval

Information provided by (Responsible Party):

Marc Fortin

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

Condition or disease

Lung Cancer

Non Small Cell Lung Cancer

Circulating Tumor Cell

Intervention/treatment

Endobronchial ultrasound

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 120 participants
Masking : Single
Masking Description : Pathologist will be blinded to study arm when analyzing samples
Primary Purpose : Diagnostic
Official Title : OPTimizing Endobronchial Ultrasound Sampling In Suspected Non Small Cell Lung Cancer for Molecular Markers : A Pragmatic Randomized Controlled TriaL
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : February 1, 2025
Arm Intervention/treatment

Experimental: 2 passes per target on EBUS

Procedure: Endobronchial ultrasound

Experimental: 3 passes per target on EBUS

Procedure: Endobronchial ultrasound

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

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Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

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