The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
Trial ID: NCT06122077
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-11-28
Completion date: 2027-06-15
Sponsor: Freenome Holdings Inc.
Conditions: Lung Cancer Diagnosis
Interventions: blood draw
Locations: Science 37; Stamford Hospital; Hillcrest Medical Research; Universal Axon Clinical Research; I.H.S Health, LLC; United Medical Research; Charter Research; Charter Research; SpeciCare, Inc; University of Chicago; Walgreens; Springfield Clinic, LLP; Aton Health; Ascension Via Christi Wichita; Ascension St. Agnes Hospital; Cape Cod Hospital; Memorial Hospital at Gulfport; Renown Regional Medical Center; Inspira Medical Center; Our Lady of Lourdes Hospital; Wakemed; Altru Health System; Hightower Clinical; Oregon Health & Science University; Clinical Research Associates of Central PA; US Digestive Health at Lancaster; Temple University; Guthrie Medical Group; US Digestive Health at Wyomissing; Medical University of South Carolina (MUSC); McLeod Health; Circle Clinical Research; The Jackson Clinic, PA; Horizon Clinical Research Group; CHRISTUS Trinity Mother Frances Health System; Ascension Columbia St. Mary's Wisconsin
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 20000
Age range: 50 Years - None
Sex: ALL

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 criteria:
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

Outcomes:
Sensitivity and specificity in detecting lung cancer