Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
Recruiting · NCT06122077 · Observational (researchers observe without assigning treatment) · Lead sponsor: Freenome Holdings Inc.
View the official record on ClinicalTrials.gov →Interventions studied
blood draw
What this trial is about
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).
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
36 locations listed across 22 US states.
- Science 37 - Los Angeles, California, United States
- Stamford Hospital - Stamford, Connecticut, United States
- Hillcrest Medical Research - DeLand, Florida, United States
- Universal Axon Clinical Research - Doral, Florida, United States
- I.H.S Health, LLC - Kissimmee, Florida, United States
- United Medical Research - Port Orange, Florida, United States
- Charter Research - The Villages, Florida, United States
- Charter Research - Winter Park, Florida, United States
- SpeciCare, Inc - Gainesville, Georgia, United States
- University of Chicago - Chicago, Illinois, United States
- Walgreens - Deerfield, Illinois, United States
- Springfield Clinic, LLP - Springfield, Illinois, United States
- Aton Health - Leawood, Kansas, United States
- Ascension Via Christi Wichita - Wichita, Kansas, United States
- Ascension St. Agnes Hospital - Baltimore, Maryland, United States
- Cape Cod Hospital - Hyannis, Massachusetts, United States
- Memorial Hospital at Gulfport - Gulfport, Mississippi, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Inspira Medical Center - Mullica Hill, New Jersey, United States
- Our Lady of Lourdes Hospital - Binghamton, New York, United States
- Wakemed - Raleigh, North Carolina, United States
- Altru Health System - Grand Forks, North Dakota, United States
- Hightower Clinical - Oklahoma City, Oklahoma, United States
- Oregon Health & Science University - Portland, Oregon, United States
- Clinical Research Associates of Central PA - DuBois, Pennsylvania, United States
- US Digestive Health at Lancaster - Lancaster, Pennsylvania, United States
- Temple University - Philadelphia, Pennsylvania, United States
- Guthrie Medical Group - Sayre, Pennsylvania, United States
- US Digestive Health at Wyomissing - Wyomissing, Pennsylvania, United States
- Medical University of South Carolina (MUSC) - Charleston, South Carolina, United States
- McLeod Health - Florence, South Carolina, United States
- Circle Clinical Research - Pierre, South Dakota, United States
- The Jackson Clinic, PA - Jackson, Tennessee, United States
- Horizon Clinical Research Group - Houston, Texas, United States
- CHRISTUS Trinity Mother Frances Health System - Tyler, Texas, United States
- Ascension Columbia St. Mary's Wisconsin - Milwaukee, Wisconsin, United States