Lung Cancer Clinical Trial
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
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 history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.
All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.
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
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 2 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 16 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
Any condition that in the opinion of the Investigator should not be enrolled in the study
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There are 4 Locations for this study
Kissimmee Florida, 34741, United States
Gainesville Georgia, 30501, United States
Deerfield Illinois, 60015, United States
Springfield Illinois, 62702, United States
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