ROSE Technique for Non-Small Cell Lung Cancer Biopsies

(ROSE/NoROSE Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Bleeding disorders, Pregnancy, Clinical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

349 Participants Needed

Trial Summary

What is the purpose of this 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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using antiplatelet or anticoagulant drugs (medications that prevent blood clots), you may not be eligible to participate.

What data supports the effectiveness of the treatment ROSE Technique for Non-Small Cell Lung Cancer Biopsies?

Research shows that the ROSE technique, which involves checking biopsy samples on the spot to ensure they are good enough for testing, can improve the chances of getting a correct diagnosis during lung cancer biopsies. This method helps doctors collect better samples, which is important for choosing the right treatment for lung cancer. ^{1 2 3 4 5}

Is the ROSE technique for lung cancer biopsies safe for humans?

The ROSE technique, used during lung cancer biopsies, has been shown to improve the success rate and reduce complications during procedures, indicating it is generally safe for humans. ^{1 2 3 4 6}

How is the ROSE technique for bronchoscopic biopsy unique for treating non-small cell lung cancer?

The ROSE technique is unique because it allows for rapid on-site evaluation of biopsy samples during a bronchoscopic procedure, ensuring that the samples are adequate for diagnosis and molecular testing. This can improve the success rate of the biopsy and reduce the need for additional procedures, which is not always possible with standard biopsy methods. ^{1 3 4 6 7}

Research Team

Lonny Yarmus, DO

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 with known or suspected non-small cell lung cancer who need a biopsy of chest structures. They must be able to consent and be referred for tissue sampling at participating sites. Pregnant women, those refusing participation, or with conditions like bleeding disorders or high oxygen needs can't join.

Inclusion Criteria

I am over 18 years old.

I have or might have non-small cell lung cancer.

I am referred for a specific lung biopsy at Johns Hopkins or affiliated sites.

Exclusion Criteria

Cytotechnologist not available at the time of screening, enrollment, or randomization

I don't have bleeding disorders, don't use blood thinners, and can breathe without high oxygen support.

I do not want to participate in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo EBUS bronchoscopy with or without ROSE to collect tissue samples for molecular marker testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for procedural complications and sufficiency of NGS biomarker testing

60 days

1 visit (in-person), additional follow-up as needed

Treatment Details

Interventions

• Bronchoscopic Biopsy
• NO-ROSE (absence of cytotech)
• ROSE (presence of cytotech)

Trial Overview The study compares two methods of bronchoscopic biopsy: one where a cytotechnologist gives immediate feedback on sample adequacy (ROSE), and another without this real-time evaluation (NO-ROSE). The goal is to see which method improves molecular marker testing.

Participant Groups

Group I: ROSE liquid arm Experimental Treatment 1 Intervention

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

Group II: ROSE clot arm Experimental Treatment 1 Intervention

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

Group III: NO-ROSE liquid arm Experimental Treatment 1 Intervention

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

Group IV: NO-ROSE clot arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

References

1. China pubmed.ncbi.nlm.nih.gov

Tissue requirements in lung cancer diagnosis for tumor heterogeneity, mutational analysis and targeted therapies: initial experience with intra-operative Frozen Section Evaluation (FROSE) in bronchoscopic biopsies. [2020]

2. China pubmed.ncbi.nlm.nih.gov

Multi-modal tissue sampling in cone beam CT guided navigation bronchoscopy: comparative accuracy of different sampling tools and rapid on-site evaluation of cytopathology. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The role of rapid on site evaluation on touch imprint cytology and brushing during conventional bronchoscopy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The Utility of Rapid On-Site Evaluation during Bronchoscopic Biopsy: A 2-Year Respiratory Endoscopy Central Experience. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of rapid on-site cytological evaluation (ROSE) by a pulmonologist in determining specimen adequacy and diagnostic accuracy in interventional diagnosis of lung lesions. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Research Advances in the Diagnostic Value of Rapid On-site Evaluation in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lung Cancer]. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. [2022]