RECRUITINGOBSERVATIONAL
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)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form and HIPAA authorization documents
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
blood 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 (20)
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