RecruitingNCT06122077

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

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

Sponsor

Freenome Holdings Inc.

Enrollment

20,000 participants

Start Date

Nov 28, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Cancer (Diagnosis)

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is validating a new blood test from a company called Freenome that may be able to detect lung cancer early, before symptoms appear, without needing a CT scan. Researchers will collect blood samples from high-risk smokers to see how accurately the test identifies lung cancer. **You may be eligible if...** - You are 50 years old or older - You are a current or former smoker with at least 20 pack-years of smoking history (e.g., 1 pack per day for 20 years) **You may NOT be eligible if...** - You are currently receiving cancer treatment (chemotherapy, radiation, surgery, immunotherapy) - You have had any cancer in the past 5 years (except non-melanoma skin cancer) - You have had an organ or bone marrow transplant - You had a lung cancer screening or chest CT scan in the past 12 months - You have symptoms that may suggest lung cancer (such as coughing up blood) - You received a blood transfusion in the past 30 days - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTblood 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.

Locations(36)

Science 37

Los Angeles, California, United States

Stamford Hospital

Stamford, Connecticut, United States

Hillcrest Medical Research

DeLand, Florida, United States

Universal Axon Clinical Research

Doral, Florida, United States

I.H.S Health, LLC

Kissimmee, Florida, United States

United Medical Research

Port Orange, Florida, United States

Charter Research

The Villages, Florida, United States

Charter Research

Winter Park, Florida, United States

SpeciCare, Inc

Gainesville, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Walgreens

Deerfield, Illinois, United States

Springfield Clinic, LLP

Springfield, Illinois, United States

Aton Health

Leawood, Kansas, United States

Ascension Via Christi Wichita

Wichita, Kansas, United States

Ascension St. Agnes Hospital

Baltimore, Maryland, United States

Cape Cod Hospital

Hyannis, Massachusetts, United States

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

Renown Regional Medical Center

Reno, Nevada, United States

Inspira Medical Center

Mullica Hill, New Jersey, United States

Our Lady of Lourdes Hospital

Binghamton, New York, United States

Wakemed

Raleigh, North Carolina, United States

Altru Health System

Grand Forks, North Dakota, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania, United States

US Digestive Health at Lancaster

Lancaster, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Guthrie Medical Group

Sayre, Pennsylvania, United States

US Digestive Health at Wyomissing

Wyomissing, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

McLeod Health

Florence, South Carolina, United States

Circle Clinical Research

Pierre, South Dakota, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

Horizon Clinical Research Group

Houston, Texas, United States

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, United States

Ascension Columbia St. Mary's Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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