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Does a Real-Time tissue check during lung biopsy boost genetic testing success?

NCT ID NCT04945317

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of doing a lung biopsy (EBUS) for people with known or suspected non-small cell lung cancer. In one group, a cytotechnologist checks the tissue sample on-site during the procedure to give feedback. In the other group, no on-site check is done. The goal is to see if on-site evaluation leads to more successful genetic testing from the biopsy tissue. About 349 participants will be enrolled at Johns Hopkins and other sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rapid on-site cytopathologic evaluation (ROSE) during bronchoscopy
What this could lead to
If successful, this could show that having a cytotechnologist on-site during bronchoscopy improves the chance of getting enough tissue for genetic testing, guiding better treatment choices for lung cancer patients.
What could go wrong
This is a procedural comparison, not a new drug or therapy. Even if ROSE improves tissue collection, it may not change patient outcomes or survival. The study is observational in nature and results may not apply to all hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 349 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer (NSCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • The Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

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