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New blood test could spare thousands from unnecessary lung surgery

NCT ID NCT04171492

Diagnosis Sponsor: Biodesix, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a blood test called Nodify XL2 can help doctors decide how to manage lung nodules that have a low to moderate chance of being cancer. About 2,000 adults with solid lung nodules between 8 and 30 mm are taking part. The goal is to see if using the test leads to better decisions, such as avoiding unnecessary biopsies or surgeries for harmless nodules.

What this could mean

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

Active substance
Nodify XL2 proteomic classifier (blood test)
What this could lead to
If successful, this test could help doctors decide which lung nodules need further testing or surgery, avoiding unnecessary invasive procedures for benign nodules.
What could go wrong
This is a large trial but results are not yet available. The test may not improve patient outcomes enough to change standard practice, and false results could still lead to missed cancers or unnecessary procedures.

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

About 2,000 people

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

Started

Dec 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects with newly identified, solid lung nodule determined to be low-moderate risk of cancer.

Ages

40 years and older

Sex

Anyone

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: 1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern 3. Subject's lung nodule of concern meets the following: * Was incidentally identified or detected during lung cancer screening * Is a solid nodule * Has maximal dimension of \> 8mm and \< 30mm 4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment 5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less Exclusion Criteria: 1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern 2. Nodule of concern is part-solid or Ground Glass Opacity (GGO) 3. Prior diagnosis of lung cancer 4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer 5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment 6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern 7. Any illness or factor that will inhibit compliance with study participation

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma pulmonary coin lesion

As listed by the trial registrant

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

Nodule solitary pulmonary Non-small cell carcinoma

Contacts and locations

Locations

  • Beth Israel Deaconess

    Boston, Connecticut, 02215, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Massachusetts General Hospital

    Boston, Connecticut, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H3H 2R9, Canada

  • MedStar

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mount Sinai Health System

    New York, New York, 10029, United States

  • Northwell Health

    New York, New York, 11042, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401, United States

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • The Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • The Ohio State University

    Coulmbus, Ohio, 43210, United States

  • The Oregon Clinic

    Portland, Oregon, 97220, United States

  • The University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • The Washington University

    St Louis, Missouri, 63110, United States

  • University of Calgary

    Calgary, Alberta, T2W 1S7, Canada

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.