Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
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.
20,000 participants
Nov 28, 2023
OBSERVATIONAL
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).
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria10
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06122077