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Non-small Cell Lung Cancer (NSCLC)ROSE/NoROSENCT04945317

ROSE for Improved Molecular Marker Testing Via EBUS

A study testing ROSE (presence of cytotech) & liquid prep, NO-ROSE (absence of cytotech) & liquid prep and ROSE (presence of cytotech) & tissue clot sample in people with Non-small Cell Lung Cancer (NSCLC), run by Johns Hopkins University at 4 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
ROSE (presence of cytotech) & liquid prep, NO-ROSE (absence of cytotech) & liquid prep and ROSE (presence of cytotech) & tissue clot sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
4 sitesUnited States
Study dates
14 May 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • The Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Northwestern Medicine

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Rapid Onsite Cytopathologic Evaluation for Improved Molecular Marker Testing Via Endobronchial Ultrasound Bronchoscopy - A Randomized Controlled Trial

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).

Read the detailed description

Endobronchial ultrasound (EBUS) is a highly safe and effective bronchoscopic procedure that can achieve diagnostic yields of over 90% for lung cancer - similar to those with the more-invasive surgical mediastinoscopy - with EBUS enjoying the advantage of a near 0% complication rate in several large studies. This has led to EBUS becoming the procedure of choice for mediastinal staging of lung cancer. Increasingly, bronchoscopists are being asked to perform EBUS not only for lung cancer staging but also for tissue acquisition for molecular markers to assess for mutations that can be treated with biologic therapy. However, a frequently encountered clinical scenario is that while an EBUS is diagnostic for lung cancer, it is non-diagnostic for molecular testing because of an insufficient amount of tissue material being collected. According to multiple studies, the "molecular yield" for EBUS in lung cancer can range from 74-82%. These studies have not specifically looked at adequacy of biomarkers, which could be distinctly different considering that evaluation of biomarkers requires more tissue for next generation sequencing (NGS). Currently, Johns Hopkins Hospital uses NGS as standard of care for identifying mutations associated with malignant cells. NGS analysis, which is usually reported as a percentage of cells that express one of many biomarkers currently being tested as standard of care, is performed via immunohistochemistry (IHC), necessitating the presence of a sufficiently cellular material with >100 tumor cells for reliable quantitative characterization. To the investigator's knowledge, the rates of NGS biomarker sufficiency have not been prospectively analyzed to date.

Rapid on-site evaluation (ROSE) is an optional step during EBUS bronchoscopy in which an on-site cytotechnologist performs a limited microscopic evaluation to provide non-binding feedback on specimen adequacy in real time during the procedure. The cytotechnologist can also aid specimen processing e.g. through creation of a "tissue clot" in addition to use of the more standard liquid-based medium. At Johns Hopkins, EBUS procedures are routinely performed both with and without ROSE since the presence or absence of ROSE during EBUS has not been shown to impact diagnostic yield or procedural safety. However, its impact on NGS biomarker sufficiency has not been tested to the investigator's knowledge.

This study aims to investigate whether ROSE can impact NGS biomarker sufficiency by assisting the bronchoscopist in obtaining adequate tissue from the appropriate site. The hypothesis is that ROSE will decrease the rate of insufficient tumor tissue to permit NGS biomarker testing.

Being tested
ROSE (presence of cytotech) & liquid prep, NO-ROSE (absence of cytotech) & liquid prep, ROSE (presence of cytotech) & tissue clot sample, NO-ROSE (absence of cytotech) & tissue clot sample
Keywords
Endobronchial ultrasound (EBUS), Rapid on-site evaluation (ROSE)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ROSE (presence of cytotech) & liquid prepOther

    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 prepOther

    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 sampleOther

    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 sampleOther

    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 groups in NCT04945317
Study groupRoleWhat they receive
ROSE clot armOtherPresence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
Receives: Other: ROSE (presence of cytotech) & tissue clot sample
NO-ROSE clot armOtherAbsence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
Receives: Other: NO-ROSE (absence of cytotech) & tissue clot sample
ROSE liquid armOtherPresence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as liquid.
Receives: Other: ROSE (presence of cytotech) & liquid prep
NO-ROSE liquid armOtherAbsence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as
Receives: Other: NO-ROSE (absence of cytotech) & liquid prep

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of NGS biomarker testing attempts

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

    Measured: within 60 days of procedure

Secondary outcomes (7)

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

    PD-1 sufficiency - amount of the protein "Programmed Cell Death Protein 1" (PD-1) expressed on immune cells = 500 cells/20% cellularity

    Measured: within 60 days of procedure

  2. Number of targets

    Number of targets (including lymph node stations, other lesions) sampled per EBUS

    Measured: During Procedure

  3. Number of passes (ROSE arms only)

    Number of passes taken from the target site

    Measured: During Procedure

  4. Number of secondary procedures

    Number of secondary procedures performed (such as radial EBUS, navigational bronchoscopy)

    Measured: During Procedure

  5. Need for repeat EBUS or another procedure

    Need for repeat EBUS or another procedure due to non-diagnostic or insufficient sample during a 30-day follow up period (binary value: yes/no)

    Measured: Within 30 days of procedure

  6. Procedure time

    Procedure time (measured in minutes)

    Measured: During Procedure

  7. Number of Procedural complications

    Procedural complications observed during a one-week follow up period

    Measured: Within 7 days of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start14 May 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center non-blinded randomized controlled trial (presence or absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist).
Masking
None (open label)
Enrolment
349 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945317
Sponsor's protocol ID
IRB00162151
Acronym
ROSE/NoROSE
Status last verified
Dec 2025
First submitted
22 Jun 2021
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21098770

  • 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.

    PubMed 19407050

  • 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.

    PubMed 19447014

  • 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.

    PubMed 23649440

  • 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.

    PubMed 28111119

  • 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.

    PubMed 25419143

  • 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.

    PubMed 23972930

  • 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.

    PubMed 22144401

  • 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.

    PubMed 23571718

Questions about this trial

What is this clinical trial studying?

A study testing ROSE (presence of cytotech) & liquid prep, NO-ROSE (absence of cytotech) & liquid prep and ROSE (presence of cytotech) & tissue clot sample in people with Non-small Cell Lung Cancer (NSCLC), run by Johns Hopkins University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of NGS biomarker testing attempts (time frame: within 60 days of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945317, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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