Clinical trial Recruiting at 36 sites Observational Ages 50 and up

Validation of a blood test for early lung cancer detection

Official title: The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Run by Freenome Holdings Inc. · NCT06122077 · Data updated 2026-11-12

This study is testing a new blood test to see if it can help detect lung cancer early in people who are at high risk.

More Lung Cancer (Diagnosis) trials

Quick facts

Study typeObservational
Ages50 Years and up
SexAll
Enrollment20000 (estimated)
SponsorFreenome Holdings Inc.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations36 sites (Los Angeles, California and 35 other locations)
StatusRecruiting
StartedNovember 28, 2023
Main results expectedJune 15, 2026
Study endsJune 15, 2027
Registry record updatedAugust 5, 2025
Trial IDNCT06122077 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 50 and older with a significant smoking history who are undergoing routine lung cancer screening.

Probably not a fit

Patients currently undergoing cancer treatment or with a recent history of malignancy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PROACT LUNG study is a prospective multi-center observational study aimed at validating the Freenome Multiomics Blood Test for early lung cancer detection. Participants who are at high risk will provide blood samples while undergoing routine low-dose computed tomography (LDCT) screening. The study will collect demographic and clinical data, including medical history and exposure factors, to evaluate the test's performance. Participants will be followed for a minimum of 24 months to assess outcomes related to lung cancer diagnosis.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of lung cancer, improving patient outcomes.

How similar studies have gone: Other studies have shown promise in using blood-based tests for cancer detection, but this specific approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age 50 years or older within 30 days of enrollment
2. Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
3. Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents

Exclusion Criteria:

1. Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
2. History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer)
3. History of organ, tissue, and bone marrow transplantation
4. Screened for lung cancer or having chest CT scan 12 months before enrollment
5. Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome
6. Received a blood transfusion in the 30 days preceding enrollment
7. Known to be pregnant
8. Participated or currently participating in another Freenome-sponsored clinical study
9. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days preceding enrollment
10. Any condition that in the opinion of the Investigator should not be enrolled in the study

Where it's running

  • Science 37
    Los Angeles, California, United States
    Recruiting
  • Stamford Hospital
    Stamford, Connecticut, United States
    Recruiting
  • Hillcrest Medical Research
    DeLand, Florida, United States
    Recruiting
  • Universal Axon Clinical Research
    Doral, Florida, United States
    Recruiting
  • I.H.S Health, LLC
    Kissimmee, Florida, United States
    Recruiting
  • United Medical Research
    Port Orange, Florida, United States
    Recruiting
Show 30 more locations
  • Charter Research
    The Villages, Florida, United States
    Recruiting
  • Charter Research
    Winter Park, Florida, United States
    Recruiting
  • SpeciCare, Inc
    Gainesville, Georgia, United States
    Recruiting
  • University of Chicago
    Chicago, Illinois, United States
    Recruiting
  • Walgreens
    Deerfield, Illinois, United States
    Recruiting
  • Springfield Clinic, LLP
    Springfield, Illinois, United States
    Recruiting
  • Aton Health
    Leawood, Kansas, United States
    Recruiting
  • Ascension Via Christi Wichita
    Wichita, Kansas, United States
    Recruiting
  • Ascension St. Agnes Hospital
    Baltimore, Maryland, United States
    Recruiting
  • Cape Cod Hospital
    Hyannis, Massachusetts, United States
    Recruiting
  • Memorial Hospital at Gulfport
    Gulfport, Mississippi, United States
    Recruiting
  • Renown Regional Medical Center
    Reno, Nevada, United States
    Recruiting
  • Inspira Medical Center
    Mullica Hill, New Jersey, United States
    Recruiting
  • Our Lady of Lourdes Hospital
    Binghamton, New York, United States
    Recruiting
  • Wakemed
    Raleigh, North Carolina, United States
    Recruiting
  • Altru Health System
    Grand Forks, North Dakota, United States
    Recruiting
  • Hightower Clinical
    Oklahoma City, Oklahoma, United States
    Recruiting
  • Oregon Health & Science University
    Portland, Oregon, United States
    Recruiting
  • Clinical Research Associates of Central PA
    DuBois, Pennsylvania, United States
    Recruiting
  • US Digestive Health at Lancaster
    Lancaster, Pennsylvania, United States
    Recruiting
  • Temple University
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Guthrie Medical Group
    Sayre, Pennsylvania, United States
    Recruiting
  • US Digestive Health at Wyomissing
    Wyomissing, Pennsylvania, United States
    Recruiting
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina, United States
    Recruiting
  • McLeod Health
    Florence, South Carolina, United States
    Recruiting
  • Circle Clinical Research
    Pierre, South Dakota, United States
    Recruiting
  • The Jackson Clinic, PA
    Jackson, Tennessee, United States
    Recruiting
  • Horizon Clinical Research Group
    Houston, Texas, United States
    Recruiting
  • CHRISTUS Trinity Mother Frances Health System
    Tyler, Texas, United States
    Recruiting
  • Ascension Columbia St. Mary's Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.