Recruiting

Observational Study

Sponsor:

Freenome Holdings Inc.

Code:

NCT06122077

Conditions

Lung Cancer Diagnosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

blood draw

Study Details

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

Study ID

NCT06122077

Start date

Nov 28, 2023

Status verified date

Aug, 2025

Completion date

Jun 15, 2027

Anticipated

Primary completion date

Jun 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Sensitivity and specificity in detecting lung cancer [ Time Frame: 12-Months ]

Central Contacts and Locations

Central contacts

Harris Naemi, BS

925-322-6486FRNM007@freenome.com

Locations

Science 37

Recruiting

Los Angeles, California, United States, 90230

Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06902

Hillcrest Medical Research

Recruiting

DeLand, Florida, United States, 32720

Universal Axon Clinical Research

Recruiting

Doral, Florida, United States, 33166

I.H.S Health, LLC

Recruiting

Kissimmee, Florida, United States, 34741

United Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Charter Research

Recruiting

The Villages, Florida, United States, 32162

Charter Research

Recruiting

Winter Park, Florida, United States, 32792

SpeciCare, Inc

Recruiting

Gainesville, Georgia, United States, 30501

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Walgreens

Recruiting

Deerfield, Illinois, United States, 60015

Springfield Clinic, LLP

Recruiting

Springfield, Illinois, United States, 62702

Aton Health

Recruiting

Leawood, Kansas, United States, 66211

Ascension Via Christi Wichita

Recruiting

Wichita, Kansas, United States, 67214

Ascension St. Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21237

Cape Cod Hospital

Recruiting

Hyannis, Massachusetts, United States, 02601

Memorial Hospital at Gulfport

Recruiting

Gulfport, Mississippi, United States, 39503

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Inspira Medical Center

Recruiting

Mullica Hill, New Jersey, United States, 08062

Our Lady of Lourdes Hospital

Recruiting

Binghamton, New York, United States, 13905

Wakemed

Recruiting

Raleigh, North Carolina, United States, 27610

Altru Health System

Recruiting

Grand Forks, North Dakota, United States, 58201

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73102

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97201

Clinical Research Associates of Central PA

Recruiting

DuBois, Pennsylvania, United States, 15801

US Digestive Health at Lancaster

Recruiting

Lancaster, Pennsylvania, United States, 17601

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Guthrie Medical Group

Recruiting

Sayre, Pennsylvania, United States, 18840

US Digestive Health at Wyomissing

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

McLeod Health

Recruiting

Florence, South Carolina, United States, 29506

Circle Clinical Research

Recruiting

Pierre, South Dakota, United States, 57104

The Jackson Clinic, PA

Recruiting

Jackson, Tennessee, United States, 38305

Horizon Clinical Research Group

Recruiting

Houston, Texas, United States, 77008

CHRISTUS Trinity Mother Frances Health System

Recruiting

Tyler, Texas, United States, 75701

Ascension Columbia St. Mary's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53211

More Information

Sponsor

Freenome Holdings Inc.

Last update posted

Aug 5, 2025

Last verified

Aug, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Freenome Holdings Inc. on 2025-08-05.