Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Recruiting now

Conditions studied: Lung Cancer Diagnosis

In brief

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

Key facts

Study ID

NCT06122077

Run by

Freenome Holdings Inc.

People needed

20000

Starts

2023-11-28

Expected to finish

2027-06-15

Last updated by the study team

2025-08-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Science 37 — Los Angeles, California, United States (enrolling)
• Stamford Hospital — Stamford, Connecticut, United States (enrolling)
• Hillcrest Medical Research — DeLand, Florida, United States (enrolling)
• Universal Axon Clinical Research — Doral, Florida, United States (enrolling)
• I.H.S Health, LLC — Kissimmee, Florida, United States (enrolling)
• United Medical Research — Port Orange, Florida, United States (enrolling)
• Charter Research — The Villages, Florida, United States (enrolling)
• Charter Research — Winter Park, Florida, United States (enrolling)
• SpeciCare, Inc — Gainesville, Georgia, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Walgreens — Deerfield, Illinois, United States (enrolling)
• Springfield Clinic, LLP — Springfield, Illinois, United States (enrolling)
• Aton Health — Leawood, Kansas, United States (enrolling)
• Ascension Via Christi Wichita — Wichita, Kansas, United States (enrolling)
• Ascension St. Agnes Hospital — Baltimore, Maryland, United States (enrolling)
• Cape Cod Hospital — Hyannis, Massachusetts, United States (enrolling)
• Memorial Hospital at Gulfport — Gulfport, Mississippi, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• Inspira Medical Center — Mullica Hill, New Jersey, United States (enrolling)
• Our Lady of Lourdes Hospital — Binghamton, New York, United States (enrolling)
• Wakemed — Raleigh, North Carolina, United States (enrolling)
• Altru Health System — Grand Forks, North Dakota, United States (enrolling)
• Hightower Clinical — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Clinical Research Associates of Central PA — DuBois, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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