Clinical trial · Interventional
ROSE for Improved Molecular Marker Testing Via EBUS
Rapid Onsite Cytopathologic Evaluation for Improved Molecular Marker Testing Via Endobronchial Ultrasound Bronchoscopy - A Randomized Controlled Trial
NCT04945317CI-TRIAL-00099178ROSE/NoROSEenrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NO-ROSE (absence of cytotech) & liquid prep | Other | — | UNRESOLVED |
| NO-ROSE (absence of cytotech) & tissue clot sample | Other | — | UNRESOLVED |
| ROSE (presence of cytotech) & liquid prep | Other | — | UNRESOLVED |
| ROSE (presence of cytotech) & tissue clot sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- ROSE clot arm
- description
- Presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
- interventionNames
- Other: ROSE (presence of cytotech) & tissue clot sample
- type
- OTHER
- label
- NO-ROSE clot arm
- description
- Absence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist. Sample prepared as tissue clot.
- interventionNames
- Other: NO-ROSE (absence of cytotech) & tissue clot sample
- type
- OTHER
- label
- ROSE liquid arm
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (9)
- BACKGROUNDAnnema 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
- BACKGROUNDVarela-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
- BACKGROUNDAnantham 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
- BACKGROUNDSilvestri 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
- BACKGROUNDSakakibara 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
- BACKGROUNDOezkan 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