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Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC (OPTIMAL)

Primary Purpose

Lung Cancer, Non Small Cell Lung Cancer, Circulating Tumor Cell

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Endobronchial ultrasound

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

2 passes per target on EBUS

3 passes per target on EBUS

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05560776

First Posted

September 25, 2022

Last Updated

September 27, 2022

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05560776

Brief Title

Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

Acronym

OPTIMAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2022 (Anticipated)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Non Small Cell Lung Cancer, Circulating Tumor Cell

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Pathologist will be blinded to study arm when analyzing samples

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2 passes per target on EBUS

Arm Type

Experimental

Arm Title

3 passes per target on EBUS

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Endobronchial ultrasound

Intervention Description

Two or three passes per lymph node

Primary Outcome Measure Information:

Title

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

Description

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.

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

Title

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

Description

Time Frame

At 1 month

Secondary Outcome Measure Information:

Title

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

Description

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.

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

Title

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

Description

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.

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Fortin, MD

Phone

4186568711

Ext

5504

marc.fortin@criucpq.ulaval.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Fortin

Organizational Affiliation

Institut Universitaire de Cardiologie et Pneumologie de Quebec

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

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