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Clinical Trials in the USA / NCT06122077
Recruiting Observational

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

NCT06122077 · tracked via the Priya Life Science USA tracker
Sponsor
Freenome Holdings Inc.
Phase
Observational
Started
2023-11-28
Last updated
2025-08-05

Condition(s) studied

Lung Cancer Diagnosis

Investigational drug(s) / intervention(s)

blood draw

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.

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Science 37 Los Angeles California Recruiting
Stamford Hospital Stamford Connecticut Recruiting
Hillcrest Medical Research DeLand Florida Recruiting
Universal Axon Clinical Research Doral Florida Recruiting
I.H.S Health, LLC Kissimmee Florida Recruiting
United Medical Research Port Orange Florida Recruiting
Charter Research The Villages Florida Recruiting
Charter Research Winter Park Florida Recruiting
SpeciCare, Inc Gainesville Georgia Recruiting
University of Chicago Chicago Illinois Recruiting
Walgreens Deerfield Illinois Recruiting
Springfield Clinic, LLP Springfield Illinois Recruiting
Aton Health Leawood Kansas Recruiting
Ascension Via Christi Wichita Wichita Kansas Recruiting
Ascension St. Agnes Hospital Baltimore Maryland Recruiting
Cape Cod Hospital Hyannis Massachusetts Recruiting
Memorial Hospital at Gulfport Gulfport Mississippi Recruiting
Renown Regional Medical Center Reno Nevada Recruiting
Inspira Medical Center Mullica Hill New Jersey Recruiting
Our Lady of Lourdes Hospital Binghamton New York Recruiting
Wakemed Raleigh North Carolina Recruiting
Altru Health System Grand Forks North Dakota Recruiting
Hightower Clinical Oklahoma City Oklahoma Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Clinical Research Associates of Central PA DuBois Pennsylvania Recruiting
US Digestive Health at Lancaster Lancaster Pennsylvania Recruiting
Temple University Philadelphia Pennsylvania Recruiting
Guthrie Medical Group Sayre Pennsylvania Recruiting
US Digestive Health at Wyomissing Wyomissing Pennsylvania Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
McLeod Health Florence South Carolina Recruiting
Circle Clinical Research Pierre South Dakota Recruiting
The Jackson Clinic, PA Jackson Tennessee Recruiting
Horizon Clinical Research Group Houston Texas Recruiting
CHRISTUS Trinity Mother Frances Health System Tyler Texas Recruiting
Ascension Columbia St. Mary's Wisconsin Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06122077 on ClinicalTrials.gov ↗ ← All trials in the USA