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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 20000 (estimated) |
| Sponsor | Freenome Holdings Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 36 sites (Los Angeles, California and 35 other locations) |
| Status | Recruiting |
| Started | November 28, 2023 |
| Main results expected | June 15, 2026 |
| Study ends | June 15, 2027 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT06122077 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
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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
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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
- Study coordinator: Harris Naemi, BS
- Email: FRNM007@freenome.com
- Phone: 925-322-6486
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.