ROSE for Improved Molecular Marker Testing Via EBUS

NCT04945317 | Enrolling By Invitation

• 1 other identifier: IRB00162151
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 4

Brief 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)

Keywords

Endobronchial ultrasound (EBUS); Rapid on-site evaluation (ROSE)

Outcome Measures

Primary Outcomes (1)

• Percentage of NGS biomarker testing attempts

  NGS biomarker sufficiency - percentage of NGS biomarker testing attempts that were successful due to sufficient tissue

  within 60 days of procedure

Secondary Outcomes (7)

• Level of Programmed Cell Death Protein 1 (PD-1)

  within 60 days of procedure

• Number of targets

  During Procedure

• Number of passes (ROSE arms only)

  During Procedure

• Number of secondary procedures

  During Procedure

• Need for repeat EBUS or another procedure

  Within 30 days of procedure

Study Arms (4)

ROSE clot arm

OTHER

Presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.

Other: ROSE (presence of cytotech) & tissue clot sample

NO-ROSE clot arm

OTHER

Absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.

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

ROSE liquid arm

OTHER

Presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as liquid.

Other: ROSE (presence of cytotech) & liquid prep

NO-ROSE liquid arm

OTHER

Absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as

Other: NO-ROSE (absence of cytotech) & liquid prep

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.

ROSE liquid arm

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.

NO-ROSE liquid arm

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.

ROSE clot arm

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.

NO-ROSE clot arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients or outpatients \>18 years old
• Capable of informed consent
• Known or suspected non-small cell lung cancer (NSCLC)
• Referred to the interventional pulmonary team at Johns Hopkins Hospital (JHH), Johns Hopkins Bayview Medical Center (JHBMC), or other participating sites for tissue sampling of a hilar/mediastinal lymph node or another lesion accessible by convex-probe (CP) EBUS

You may not qualify if:

• Refuse participation
• Standard contraindications to EBUS and bronchoscopy in general: bleeding disorders, antiplatelet or anticoagulant usage, high fraction of inspired oxygen (FiO2) requirement, and clinical instability
• Pregnant women
• Cytotechnologist not available at the time of screening, enrollment, or randomization

Sponsors & Collaborators

• Johns Hopkins University: lead
• AstraZeneca: collaborator

Study Sites (4)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

The Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Related Publications (9)

• Annema JT, van Meerbeeck JP, Rintoul RC, Dooms C, Deschepper E, Dekkers OM, De Leyn P, Braun J, Carroll NR, Praet M, de Ryck F, Vansteenkiste J, Vermassen F, Versteegh MI, Veselic M, Nicholson AG, Rabe KF, Tournoy KG. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010 Nov 24;304(20):2245-52. doi: 10.1001/jama.2010.1705.

  PMID: 21098770 BACKGROUND

• Varela-Lema L, Fernandez-Villar A, Ruano-Ravina A. Effectiveness and safety of endobronchial ultrasound-transbronchial needle aspiration: a systematic review. Eur Respir J. 2009 May;33(5):1156-64. doi: 10.1183/09031936.00097908.

  PMID: 19407050 BACKGROUND

• Anantham D, Koh MS, Ernst A. Endobronchial ultrasound. Respir Med. 2009 Oct;103(10):1406-14. doi: 10.1016/j.rmed.2009.04.010. Epub 2009 May 15.

  PMID: 19447014 BACKGROUND

• Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.

  PMID: 23649440 BACKGROUND

• Sakakibara R, Inamura K, Tambo Y, Ninomiya H, Kitazono S, Yanagitani N, Horiike A, Ohyanagi F, Matsuura Y, Nakao M, Mun M, Okumura S, Inase N, Nishio M, Motoi N, Ishikawa Y. EBUS-TBNA as a Promising Method for the Evaluation of Tumor PD-L1 Expression in Lung Cancer. Clin Lung Cancer. 2017 Sep;18(5):527-534.e1. doi: 10.1016/j.cllc.2016.12.002. Epub 2016 Dec 22.

  PMID: 28111119 BACKGROUND

• Oezkan F, Khan A, Zarogoulidis P, Hohenforst-Schmidt W, Theegarten D, Yasufuku K, Nakajima T, Freitag L, Darwiche K. Efficient utilization of EBUS-TBNA samples for both diagnosis and molecular analyses. Onco Targets Ther. 2014 Nov 10;7:2061-5. doi: 10.2147/OTT.S72974. eCollection 2014.

  PMID: 25419143 BACKGROUND

• Jurado J, Saqi A, Maxfield R, Newmark A, Lavelle M, Bacchetta M, Gorenstein L, Dovidio F, Ginsburg ME, Sonett J, Bulman W. The efficacy of EBUS-guided transbronchial needle aspiration for molecular testing in lung adenocarcinoma. Ann Thorac Surg. 2013 Oct;96(4):1196-1202. doi: 10.1016/j.athoracsur.2013.05.066. Epub 2013 Aug 21.

  PMID: 23972930 BACKGROUND

• Yung RC, Otell S, Illei P, Clark DP, Feller-Kopman D, Yarmus L, Askin F, Gabrielson E, Li QK. Improvement of cellularity on cell block preparations using the so-called tissue coagulum clot method during endobronchial ultrasound-guided transbronchial fine-needle aspiration. Cancer Cytopathol. 2012 Jun 25;120(3):185-95. doi: 10.1002/cncy.20199. Epub 2011 Dec 5.

  PMID: 22144401 BACKGROUND

• Oki M, Saka H, Kitagawa C, Kogure Y, Murata N, Adachi T, Ando M. Rapid on-site cytologic evaluation during endobronchial ultrasound-guided transbronchial needle aspiration for diagnosing lung cancer: a randomized study. Respiration. 2013;85(6):486-92. doi: 10.1159/000346987. Epub 2013 Apr 3.

  PMID: 23571718 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lonny Yarmus, DO, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: blinding not possible given nature of intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center non-blinded randomized controlled trial (presence or absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist).

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: May 14, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)