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New biomarker model aims to reduce unnecessary lung biopsies

NCT ID NCT06074133

Diagnosis Sponsor: Vanderbilt-Ingram Cancer Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a combined biomarker model (CBM) that uses a blood test and CT scan features to better classify lung nodules as benign or cancerous. Researchers will follow 103 adults with intermediate-risk nodules to see if the model can reduce unnecessary invasive procedures and speed up cancer diagnosis. It is an observational pilot study, not a treatment trial.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate way to tell if a lung nodule is cancerous, helping patients avoid unnecessary invasive tests.
What could go wrong
This is a small, early pilot study (103 participants) that is only observing outcomes, not testing a treatment. The model may not prove accurate enough in larger trials.

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.

Participants

103 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Mar 2029

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.

Who is studied

Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules

Ages

21 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: * Adults \> 21 y/o * IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model * Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model * Solid nodules or part-solid nodules with solid component \>=8mm * CT scan with nodule of concern performed within 60 days of enrollment Exclusion Criteria: Pure ground glass nodule or subsolid nodule with solid component \<8mm * Currently on therapy for any cancer * History of primary lung cancer within the last 5 years * Multiple nodules highly suspicious for metastatic disease * Other malignancy within the last 2 year - Excluding skin cancer other than melanoma * Pregnant women * Prisoners * Inability to provide informed consent * Serologic evidence of active fungal infection

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As listed by the trial registrant

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

Pulmonary nodule

Contacts and locations

Locations

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • VA Tennessee Valley Healthcare Center

    Nashville, Tennessee, 37212, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37203, United States

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