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ROSE for Improved Molecular Marker Testing Via EBUS

NCT04945317 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2025-12-17

No results posted yet for this study

Summary

This research study is being done to compare two ways to conduct bronchoscopic biopsy of lymph nodes and other structures in the chest (i.e. the presence or absence of an on-site cytotechnologist performing a limited microscopic evaluation to provide non-binding feedback on specimen adequacy in real time during the procedure).

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

OTHER

ROSE (presence of cytotech) & liquid prep

Standard of care EBUS will include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is liquid.

OTHER

NO-ROSE (absence of cytotech) & liquid prep

Standard of care EBUS will NOT include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is liquid.

OTHER

ROSE (presence of cytotech) & tissue clot sample

Standard of care EBUS will include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is a tissue clot.

OTHER

NO-ROSE (absence of cytotech) & tissue clot sample

Standard of care EBUS will NOT include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is a tissue clot.

Sponsors & Collaborators

Principal Investigators

  • Lonny Yarmus, DO, MBA · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945317 on ClinicalTrials.gov