Actively Recruiting
The PROACT LUNG Study: Observational Clinical Validation of the Freenome Multiomics Blood Test for Lung Cancer Screening
Led by Freenome Holdings Inc. · Updated on 2025-08-05
20000
Participants Needed
36
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography (LDCT) screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood test's sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.
CONDITIONS
Brief Title
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older within 30 days of enrollment
- Current or former smokers with a smoking history of 20 or more pack-years
- Able to understand and willing to sign informed consent and HIPAA authorization
You will not qualify if you...
- Receiving any active cancer therapy such as surgery, chemotherapy, biologic therapy, immunotherapy, or radiation at enrollment
- History of any cancer within 5 years before enrollment except non-melanoma skin cancer
- History of organ, tissue, or bone marrow transplantation
- Had lung cancer screening or chest CT scan within 12 months before enrollment
- Signs or symptoms of lung cancer such as coughing up blood, superior vena cava syndrome, Cushing syndrome, or Pancoast syndrome
- Blood transfusion in the 30 days before enrollment
- Known pregnancy
- Participated or currently participating in another Freenome-sponsored clinical study
- Participated or currently participating in a clinical trial involving experimental medication within 60 days before enrollment
- Any condition deemed by the Investigator to make participation unsafe or inappropriate
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Up to 45 days after enrollment
Participants provide a blood sample and undergo a screening chest CT scan as part of standard care to evaluate for lung cancer.
1 visit for blood draw and screening chest CT scan
Duration - At least 24 months
Participants are followed for clinical outcomes and diagnostic results related to lung cancer over a period of at least 24 months.
Follow-up assessments as part of routine clinical care
Trial Site Locations
Total: 36 locations
1
Science 37
Los Angeles, California, United States, 90230
Actively Recruiting
2
Stamford Hospital
Stamford, Connecticut, United States, 06902
Actively Recruiting
3
Hillcrest Medical Research
DeLand, Florida, United States, 32720
Actively Recruiting
4
Universal Axon Clinical Research
Doral, Florida, United States, 33166
Actively Recruiting
5
I.H.S Health, LLC
Kissimmee, Florida, United States, 34741
Actively Recruiting
6
United Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
7
Charter Research
The Villages, Florida, United States, 32162
Actively Recruiting
8
Charter Research
Winter Park, Florida, United States, 32792
Actively Recruiting
9
SpeciCare, Inc
Gainesville, Georgia, United States, 30501
Actively Recruiting
10
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
11
Walgreens
Deerfield, Illinois, United States, 60015
Actively Recruiting
12
Springfield Clinic, LLP
Springfield, Illinois, United States, 62702
Actively Recruiting
13
Aton Health
Leawood, Kansas, United States, 66211
Actively Recruiting
14
Ascension Via Christi Wichita
Wichita, Kansas, United States, 67214
Actively Recruiting
15
Ascension St. Agnes Hospital
Baltimore, Maryland, United States, 21237
Actively Recruiting
16
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Actively Recruiting
17
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States, 39503
Actively Recruiting
18
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
19
Inspira Medical Center
Mullica Hill, New Jersey, United States, 08062
Actively Recruiting
20
Our Lady of Lourdes Hospital
Binghamton, New York, United States, 13905
Actively Recruiting
21
Wakemed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
22
Altru Health System
Grand Forks, North Dakota, United States, 58201
Actively Recruiting
23
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
24
Oregon Health & Science University
Portland, Oregon, United States, 97201
Actively Recruiting
25
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
26
US Digestive Health at Lancaster
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
27
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
28
Guthrie Medical Group
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
29
US Digestive Health at Wyomissing
Wyomissing, Pennsylvania, United States, 19610
Actively Recruiting
30
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
31
McLeod Health
Florence, South Carolina, United States, 29506
Actively Recruiting
32
Circle Clinical Research
Pierre, South Dakota, United States, 57104
Actively Recruiting
33
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38305
Actively Recruiting
34
Horizon Clinical Research Group
Houston, Texas, United States, 77008
Actively Recruiting
35
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States, 75701
Actively Recruiting
36
Ascension Columbia St. Mary's Wisconsin
Milwaukee, Wisconsin, United States, 53211
Actively Recruiting
Research Team
H
Harris Naemi, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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