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Blood test could spot lung cancer early in smokers

NCT ID NCT05306288

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing a new blood test (called DELFI) to see how well it can find lung cancer in people at high risk, such as current or former smokers aged 50 and older. Over 11,000 participants provided blood samples, and the test results were compared with standard CT scans and follow-up. The goal is to improve early detection of lung cancer, which could lead to earlier treatment and better outcomes.

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

11,935 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Oct 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

Participants will be men and women, current or former smokers, ≥ 50 years of age who are scheduled for a standard-of-care screening chest CT scan.

Ages

50 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: * All subjects 1. Ability to understand and provide written informed consent 2. Age ≥ 50 years 3. Current or former smoker 4. ≥ 20 pack-years (pack years = number of packs per day × number of years smoked) 5. An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan) Exclusion Criteria: * All subjects 1. Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment 2. Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies) 3. Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment 4. Any history of organ tissue transplantation 5. Any history of blood product transfusion within 120 days prior to enrollment 6. Current pregnancy 7. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study 8. Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • Advanced Research

    Boynton Beach, Florida, 33347, United States

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224, United States

  • American Clinical Trials, LLC.

    Acworth, Georgia, 30101, United States

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120, United States

  • CHRISTUS St. Vincent Regional Medical Center

    Santa Fe, New Mexico, 87505, United States

  • CHRISTUS Trinity Clinic Pulmonary Medicine

    Irving, Texas, 75038, United States

  • Central Virginia VA Health System: Hunter Holmes McGuire

    Richmond, Virginia, 23249, United States

  • Centricity Research Columbus Piedmont

    Columbus, Georgia, 31904, United States

  • Centricity Research Gwinnett Pulmonology

    Lawrenceville, Georgia, 30046, United States

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31326, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • ClinCept, LLC

    Columbus, Georgia, 31904, United States

  • Clinical Research Associates of Central Pa, LLC

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research of California LLC

    Walnut Creek, California, 94598, United States

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562, United States

  • Coastal Heritage Clinical Research

    Hinesville, Georgia, 31313, United States

  • Cullman Clinical Trials

    Cullman, Alabama, 35055, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Durham VA

    Durham, North Carolina, 27705, United States

  • Galenus Group

    Lehigh Acres, Florida, 33936, United States

  • Greater Heights Memorial Pulmonary and Sleep

    Houston, Texas, 77008, United States

  • Hannibal Regional Healthcare System

    Hannibal, Missouri, 63401, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134, United States

  • Hoag Hospital

    Newport Beach, California, 92663, United States

  • Houston Pulmonary Sleep and Allergy Associates

    Houston, Texas, 77070, United States

  • Internal Medicine Associate

    Bridgeton, New Jersey, 08302, United States

  • Johns Hopkins

    Baltimore, Maryland, 21224, United States

  • LLM Research

    Myrtle Beach, South Carolina, 29577, United States

  • Lumi Research

    Kingwood, Texas, 77339, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29407, United States

  • Minneapolis VA

    Minneapolis, Minnesota, 55417, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • North Houston Cancer Clinics

    Huntsville, Texas, 77340, United States

  • Northwest Research Center

    Portland, Oregon, 97202, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Ochsner

    New Orleans, Louisiana, 70121, United States

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Pan American Center for Oncology Trials

    San Juan, 902, Puerto Rico

  • Paradigm Clinical Research Center

    Wheat Ridge, Colorado, 80033, United States

  • Paradigm Clinical Research Center, Inc.

    Redding, California, 96001, United States

  • Pittsburgh VA Healthcare System

    Pittsburgh, Pennsylvania, 15217, United States

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345, United States

  • Pulmonary Research Institute of Southeast Michigan

    Farmington Hills, Michigan, 48336, United States

  • R&H Clinical Research, Inc.

    Katy, Texas, 77494, United States

  • Ralph H Johnson VA

    Charleston, South Carolina, 28401, United States

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • SCL Health Research Institute, St. Mary's

    Grand Junction, Colorado, 81501, United States

  • SIMEDHealth, LLC

    Gainesville, Florida, 32607, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • San Francisco VA

    San Francisco, California, 94121, United States

  • Science 37 (nationwide digital enrollment)

    Culver City, California, 90230, United States

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Springfield Clinic

    Springfield, Illinois, 62703, United States

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Stamford Health

    Stamford, Connecticut, 06904, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055, United States

  • United Medical Research

    Port Orange, Florida, 32127, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45069, United States

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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