ROSE Technique for Non-Small Cell Lung Cancer Biopsies
(ROSE/NoROSE Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Dr. Lonny Yarmus, DO - Baltimore, MD ...

Overseen byJeffrey Thiboutot, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

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).

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.

+1 more

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.

+1 more

Participant Groups

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.

4Treatment groups

Experimental Treatment

Group I: ROSE liquid armExperimental Treatment1 Intervention

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

Group II: ROSE clot armExperimental Treatment1 Intervention

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

Group III: NO-ROSE liquid armExperimental Treatment1 Intervention

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

Group IV: NO-ROSE clot armExperimental Treatment1 Intervention

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