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Trial Title:
Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
NCT ID:
NCT05560776
Condition:
Lung Cancer
Non Small Cell Lung Cancer
Circulating Tumor Cell
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Masking description:
Pathologist will be blinded to study arm when analyzing samples
Intervention:
Intervention type:
Procedure
Intervention name:
Endobronchial ultrasound
Description:
Two or three passes per lymph node
Arm group label:
2 passes per target on EBUS
Arm group label:
3 passes per target on EBUS
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2022
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Agency class:
Other
Source:
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05560776
