ROSE for Improved Molecular Marker Testing Via EBUS

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Johns Hopkins University
Study ID
NCT04945317
Status
Enrolling By Invitation

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ROSE (presence of cytotech) & liquid prep — OTHER
    Standard of care EBUS will include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is liquid.
  • NO-ROSE (absence of cytotech) & liquid prep — OTHER
    Standard of care EBUS will NOT include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure. Sample is liquid.
  • ROSE (presence of cytotech) & tissue clot sample — OTHER
    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.
  • NO-ROSE (absence of cytotech) & tissue clot sample — OTHER
    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.

Study Details

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).

Key Dates

Start date
May 14, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
349 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: ROSE clot arm
    Presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
  • Other: NO-ROSE clot arm
    Absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
  • Other: ROSE liquid arm
    Presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as liquid.
  • Other: NO-ROSE liquid arm
    Absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as

Primary Outcome Measure

Percentage of NGS biomarker testing attempts [ Time Frame: within 60 days of procedure ]

Locations (4)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611-
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-
Johns Hopkins HospitalBaltimoreMaryland21287-
The Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-

Find similar trials in Chicago, IL

By research site
Northwestern Medicine· Chicago, ILJohns Hopkins Bayview Medical Center· Baltimore, MDJohns Hopkins Hospital· Baltimore, MDThe Medical University of South Carolina (MUSC)· Charleston, SC

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