Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

Lung Cancer Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05560776
• Other study ID #: 2023-3850
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2022
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Marc Fortin, MD
• Phone: 4186568711
• Email: marc.fortin[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Circulating Tumor Cell
• Lung Cancer
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Non Small Cell Lung Cancer

Intervention

Procedure:
• Endobronchial ultrasound
Two or three passes per lymph node

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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