Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening (PROACT-LUNG)

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

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).

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Diagnosis
• Intervention / Treatment: Diagnostic test: blood draw

Detailed Description

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT.

The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Harris Naemi, BS; Phone Number: 925-322-6486; Email: FRNM007@freenome.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90230
      • Recruiting
      • Science 37
      • Contact: Study Coordinator
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Recruiting
      • Stamford Hospital
      • Contact: Study Coordinator
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Hillcrest Medical Research
      • Contact: Study Coordinator
    • Doral, Florida, United States, 33166
      • Recruiting
      • Universal Axon Clinical Research
      • Contact: Study Coordinator
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • I.H.S Health, LLC
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • United Medical Research
      • Contact: Study Coordinator
    • The Villages, Florida, United States, 32162
      • Recruiting
      • Charter Research
      • Contact: Study Coordinator
    • Winter Park, Florida, United States, 32792
      • Recruiting
      • Charter Research
      • Contact: Study Coordinator
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • SpeciCare, Inc
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Study Coordinator
    • Deerfield, Illinois, United States, 60015
      • Recruiting
      • Walgreens
      • Contact: Study Coordinator
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Springfield Clinic, Llp
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Recruiting
      • Aton Health
      • Contact: Study Coordinator
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi Wichita
      • Contact: Study Coordinator
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Recruiting
      • Ascension St. Agnes Hospital
      • Contact: Study Coordinator
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Recruiting
      • Cape Cod Hospital
      • Contact: Study Coordinator
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Recruiting
      • Memorial Hospital at Gulfport
      • Contact: Study Coordinator
  • Nevada
    • Reno, Nevada, United States, 89502
      • Recruiting
      • Renown Regional Medical Center
      • Contact: Study Coordinator
  • New Jersey
    • Mullica Hill, New Jersey, United States, 08062
      • Recruiting
      • Inspira Medical Center
  • New York
    • Binghamton, New York, United States, 13905
      • Recruiting
      • Our Lady of Lourdes Hospital
      • Contact: Study Coordinator
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed
      • Contact: Study Coordinator
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Recruiting
      • Altru Health System
      • Contact: Study Coordinator
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Recruiting
      • Hightower Clinical
  • Oregon
    • Portland, Oregon, United States, 97201
      • Recruiting
      • Oregon Health & Science University
      • Contact: Study Coordinator
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Recruiting
      • Clinical Research Associates of Central PA
      • Contact: Study Coordinator
    • Lancaster, Pennsylvania, United States, 17601
      • Recruiting
      • US Digestive Health at Lancaster
      • Contact: Study Coordinator
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Study Coordinator
    • Sayre, Pennsylvania, United States, 18840
      • Recruiting
      • Guthrie Medical Group
      • Contact: Study Coordinator
    • Wyomissing, Pennsylvania, United States, 19610
      • Recruiting
      • US Digestive Health at Wyomissing
      • Contact: Study Coordinator
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina (MUSC)
      • Contact: Study Coordinator
    • Florence, South Carolina, United States, 29506
      • Recruiting
      • McLeod Health
      • Contact: Study Coordinator
  • South Dakota
    • Pierre, South Dakota, United States, 57104
      • Recruiting
      • Circle Clinical Research
      • Contact: Study Coordinator
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Recruiting
      • The Jackson Clinic, PA
      • Contact: Study Coordinator
  • Texas
    • Houston, Texas, United States, 77008
      • Recruiting
      • Horizon Clinical Research Group
      • Contact: Study Coordinator
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Christus Trinity Mother Frances Health System
      • Contact: Study Coordinator
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Recruiting
      • Ascension Columbia St. Mary's Wisconsin
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study aims to enroll a representative sample of the population across the United States including adults aged 50 years and older who have at least a 20-pack-year smoking history and who have met the eligibility criteria defined in this protocol.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity in detecting lung cancer	Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period	12-Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity in detecting lung cancer	Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period	24-Months

Collaborators and Investigators

• Sponsor: Freenome Holdings Inc.
• Investigators: Study Director: Victoria Sumner, Freenome Holdings Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer; Artificial Intelligence; Genomics; Liquid Biopsy; Emphysema; Chronic obstructive pulmonary disease (COPD); Machine Learning; Cancer Screening; Acute respiratory distress syndrome (ARDS); Chronic bronchitis; Cancer Diagnostic; Multiomics; Lung Cancer Screening; Blood Test Cancer; Genomics Test; Cancer Early Detection Test; Freenome Test; Lung nodules; LDCT Screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: FRNM-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No