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Breath and blood tests could spot lung cancer early

NCT ID NCT04165564

Diagnosis Sponsor: Boston 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether biomarkers found in blood and airway samples can help predict lung cancer in people with suspicious lung nodules. Researchers will collect samples from 85 high-risk smokers and compare them to standard imaging results. The goal is to improve how doctors diagnose lung cancer without relying solely on invasive procedures.

What this could mean

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

Active substance
Biosamples of airway and blood
What this could lead to
If successful, this could lead to a simple, noninvasive test that helps doctors tell whether a lung nodule is cancerous or not, reducing unnecessary procedures.
What could go wrong
This is a small, early-stage study (85 participants) focused on biomarker validation, not a treatment. The biomarkers may not prove accurate enough for widespread use.

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

85 people

The number who actually took part.

Started

Aug 2020

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.

Who is studied

Patients are identified for inclusion in the study based on the observation of a lung nodule on screening or incidentally found by routine chest CT scans, between 0.8-2.5 cm diameter or observation of a mixed density nodule in which the solid portion is 0.6-2.5 cm diameter. These patients are managed according to institutional standard of care. This may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)

Ages

46 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: * Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm) identified in the past 3 months OR semi-solid (mixed density) nodule with solid component of at least 0.6 cm identified in the past 12 months; must be of appropriate size at enrollment. * CT scan completed within 3 months prior to enrollment * Able to tolerate all biospecimen collection as required by protocol * Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for approximately three years from enrollment * Able to complete the Patient Lung History questionnaire with study staff Arm 1 - Screening * Age 55-77 years old * Current and former smokers with 30 pack-years or more(and quit less than 15 years ago) Arm 2 - Incidental * Age \> 45 years old * Current and former smokers with 10 pack-years or more(and quit less than 15 years ago) Exclusion Criteria: * History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer) * Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis) * Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above)

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Conditions

The condition(s) this trial relates to.

lung disorder

As listed by the trial registrant

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

Pulmonary disease

Contacts and locations

Locations

  • American College of Radiology [Administrative Site]

    Philadelphia, Pennsylvania, 19103, United States

  • Brown University [Administrative Site]

    Providence, Rhode Island, 02912, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • MD Anderson Cancer Center [Administrative Site]

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia, 23708, United States

  • Naval Medical Center San Diego

    San Diego, California, 92134, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • VA Boston Healthcare System

    Boston, Massachusetts, 02110, United States

  • VA Greater LA Healthcare System

    Los Angeles, California, 90095, United States

  • VA Tennessee Valley Healthcare System

    Nashville, Tennessee, 37232, United States

  • Walter Reed Army Medical Center

    Bethesda, Maryland, 20889, United States

  • West Virginia University

    Morgantown, West Virginia, 26505, United States

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