What is the Freenome Multiomics Blood Test studying for lung cancer?

The Freenome Multiomics Blood Test is being studied to see how well it can detect lung cancer early in high-risk individuals. This study compares the blood test results to standard chest CT scans to evaluate its accuracy. The research is sponsored by Freenome Holdings Inc. and aims to improve lung cancer screening methods.

Who may be eligible for this lung cancer clinical trial?

Adults aged 50 years or older who are current or former smokers with a history of at least 20 pack-years may be eligible. Participants should not be undergoing active cancer treatment or have had a chest CT scan for lung cancer in the past year. The study welcomes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this lung cancer clinical trial?

Study-related care, including the blood test and all trial visits, is provided at no cost. However, personal travel or other expenses to attend visits may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 50Years +

All Genders

ID06122077

The PROACT LUNG Study Observational Clinical Validation of the Freenome Multiomics Blood Test for Lung Cancer Screening

Led by Freenome Holdings Inc. · Updated on 2025-08-05

20000

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography LDCT screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood tests sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.

CONDITIONS

Brief Title

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Who Can Participate

Age: 50Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 50 years or older within 30 days of enrollment
Current or former smokers with a smoking history of 20 or more pack-years
Able to understand and willing to sign informed consent and HIPAA authorization

You will not qualify if you...

Receiving any active cancer therapy such as surgery, chemotherapy, biologic therapy, immunotherapy, or radiation at enrollment
History of any cancer within 5 years before enrollment except non-melanoma skin cancer
History of organ, tissue, or bone marrow transplantation
Had lung cancer screening or chest CT scan within 12 months before enrollment
Signs or symptoms of lung cancer such as coughing up blood, superior vena cava syndrome, Cushing syndrome, or Pancoast syndrome
Blood transfusion in the 30 days before enrollment
Known pregnancy
Participated or currently participating in another Freenome-sponsored clinical study
Participated or currently participating in a clinical trial involving experimental medication within 60 days before enrollment
Any condition deemed by the Investigator to make participation unsafe or inappropriate

Research Team

Harris Naemi, BS

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