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Active, Not Recruiting

NCT Number: NCT05560776

Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Circulating Tumor Cell Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Non Small Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et Pneumologie de Quebec

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobronchial Ultrasound

Procedure

Two or three passes per lymph node

Primary outcomes

  1. Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node

    Time frame: 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.

  2. Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy

    Time frame: 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 outcomes

  1. Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/patient

    Time frame: 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.

  2. Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/sampling scheme

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: OPTIMAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2022
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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