Lung Cancer, Non Small Cell Lung Cancer, Circulating Tumor Cell
Conditions
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
Interventions
PROCEDUREEndobronchial ultrasound
Two or three passes per lymph node
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Pathologist will be blinded to study arm when analyzing samples
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node | 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. |
| Percentage of patients for which liquid biopsy allowed to identify genetic alterations not identified from tissue biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMarc Fortin
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Outcome results
None listed