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Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Sponsored by Freenome Holdings Inc.

About this study

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).

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer. Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT. The study will also collect demographic data and relevant clinical data, such as medical hi…

Where this study is enrolling (3)

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.