The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
Freenome Holdings Inc.
Summary
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).
Description
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 col…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 marro…
Interventions
- Diagnostic Testblood draw
Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.
Locations (36)
- Science 37Los Angeles, California
- Stamford HospitalStamford, Connecticut
- Hillcrest Medical ResearchDeLand, Florida
- Universal Axon Clinical ResearchDoral, Florida
- I.H.S Health, LLCKissimmee, Florida
- United Medical ResearchPort Orange, Florida