Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

NCT06122077 | Recruiting DMC

• 1 other identifier: FRNM-007
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 36

Brief 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).

Conditions

Lung Cancer Diagnosis

Keywords

Artificial Intelligence; Liquid Biopsy; Blood Test Cancer; Cancer Diagnostic; Genomics; Genomics Test; Multiomics; Cancer Screening; Cancer Early Detection Test; LDCT Screening; Lung Cancer Screening; Lung Cancer; Freenome Test; Machine Learning; Acute respiratory distress syndrome (ARDS); Chronic obstructive pulmonary disease (COPD); Chronic bronchitis; Emphysema; Lung nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and specificity in detecting lung cancer

  24-Months

Interventions

blood draw DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Sex assigned at birth
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 50 years or older within 30 days of enrollment
• Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
• Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents

You may not qualify if:

• Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
• History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer)
• History of organ, tissue, and bone marrow transplantation
• Screened for lung cancer or having chest CT scan 12 months before enrollment
• Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome
• Received a blood transfusion in the 30 days preceding enrollment
• Known to be pregnant
• Participated or currently participating in another Freenome-sponsored clinical study
• Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days preceding enrollment
• Any condition that in the opinion of the Investigator should not be enrolled in the study

Sponsors & Collaborators

• Freenome Holdings Inc.: lead

Study Sites (36)

Science 37

Los Angeles, California, 90230, United States

RECRUITING

Stamford Hospital

Stamford, Connecticut, 06902, United States

RECRUITING

Hillcrest Medical Research

DeLand, Florida, 32720, United States

RECRUITING

Universal Axon Clinical Research

Doral, Florida, 33166, United States

RECRUITING

I.H.S Health, LLC

Kissimmee, Florida, 34741, United States

RECRUITING

United Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Charter Research

The Villages, Florida, 32162, United States

RECRUITING

Charter Research

Winter Park, Florida, 32792, United States

RECRUITING

SpeciCare, Inc

Gainesville, Georgia, 30501, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Walgreens

Deerfield, Illinois, 60015, United States

RECRUITING

Springfield Clinic, LLP

Springfield, Illinois, 62702, United States

RECRUITING

Aton Health

Leawood, Kansas, 66211, United States

RECRUITING

Ascension Via Christi Wichita

Wichita, Kansas, 67214, United States

RECRUITING

Ascension St. Agnes Hospital

Baltimore, Maryland, 21237, United States

RECRUITING

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

RECRUITING

Memorial Hospital at Gulfport

Gulfport, Mississippi, 39503, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Inspira Medical Center

Mullica Hill, New Jersey, 08062, United States

RECRUITING

Our Lady of Lourdes Hospital

Binghamton, New York, 13905, United States

RECRUITING

Wakemed

Raleigh, North Carolina, 27610, United States

RECRUITING

Altru Health System

Grand Forks, North Dakota, 58201, United States

RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97201, United States

RECRUITING

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

RECRUITING

US Digestive Health at Lancaster

Lancaster, Pennsylvania, 17601, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

RECRUITING

US Digestive Health at Wyomissing

Wyomissing, Pennsylvania, 19610, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

McLeod Health

Florence, South Carolina, 29506, United States

RECRUITING

Circle Clinical Research

Pierre, South Dakota, 57104, United States

RECRUITING

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

RECRUITING

Horizon Clinical Research Group

Houston, Texas, 77008, United States

RECRUITING

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

RECRUITING

Ascension Columbia St. Mary's Wisconsin

Milwaukee, Wisconsin, 53211, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

MeSH Terms

Conditions

Lung Neoplasms; Respiratory Distress Syndrome; Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Victoria Sumner

  Freenome Holdings Inc.

  STUDY DIRECTOR

Central Study Contacts

Harris Naemi, BS

CONTACT

925-322-6486; FRNM007@freenome.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)