Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06122077 | RECRUITING | Lung Cancer Diagnosis

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
Sponsor:

Freenome Holdings Inc.

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).

Condition or disease

Lung Cancer Diagnosis

Intervention/treatment

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
Estimated Enrollment : 20000 participants
Official Title : The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
Actual Study Start Date : 2023-11-28
Estimated Primary Completion Date : 2026-06-15
Estimated Study Completion Date : 2027-06-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Criteria
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
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Location Details

NCT06122077

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Science 37

Los Angeles, California, United States, 90230

RECRUITING

United States, Connecticut

Stamford Hospital

Stamford, Connecticut, United States, 06902

RECRUITING

United States, Florida

Hillcrest Medical Research

DeLand, Florida, United States, 32720

RECRUITING

United States, Florida

Universal Axon Clinical Research

Doral, Florida, United States, 33166

RECRUITING

United States, Florida

I.H.S Health, LLC

Kissimmee, Florida, United States, 34741

RECRUITING

United States, Florida

United Medical Research

Port Orange, Florida, United States, 32127

RECRUITING

United States, Florida

Charter Research

The Villages, Florida, United States, 32162

RECRUITING

United States, Florida

Charter Research

Winter Park, Florida, United States, 32792

RECRUITING

United States, Georgia

SpeciCare, Inc

Gainesville, Georgia, United States, 30501

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Illinois

Walgreens

Deerfield, Illinois, United States, 60015

RECRUITING

United States, Illinois

Springfield Clinic, LLP

Springfield, Illinois, United States, 62702

RECRUITING

United States, Kansas

Aton Health

Leawood, Kansas, United States, 66211

RECRUITING

United States, Kansas

Ascension Via Christi Wichita

Wichita, Kansas, United States, 67214

RECRUITING

United States, Maryland

Ascension St. Agnes Hospital

Baltimore, Maryland, United States, 21237

RECRUITING

United States, Massachusetts

Cape Cod Hospital

Hyannis, Massachusetts, United States, 02601

RECRUITING

United States, Mississippi

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States, 39503

RECRUITING

United States, Nevada

Renown Regional Medical Center

Reno, Nevada, United States, 89502

RECRUITING

United States, New Jersey

INSPIRATION MEDICAL CENTER

Mullica Hill, New Jersey, United States, 08062

RECRUITING

United States, New York

Our Lady of Lourdes Hospital

Binghamton, New York, United States, 13905

RECRUITING

United States, North Carolina

Wakemed

Raleigh, North Carolina, United States, 27610

RECRUITING

United States, North Dakota

Altru Health System

Grand Forks, North Dakota, United States, 58201

RECRUITING

United States, Oklahola

Hightower Clinical

Ololama City, Okholohan, United States, 73102

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97201

RECRUITING

United States, Pennsylvania

Clinical Research Associates of Central PA

Dubois, Pennsylvania, United States, 15801

RECRUITING

United States, Pennsylvania

US Digestive Health at Lancaster

Lancaster, Pennsylvania, United States, 17601

RECRUITING

United States, Pennsylvania

Temple University

Philadelphia, Pennsylvania, United States, 19140

RECRUITING

United States, Pennsylvania

Guthrie Medical Group

Sayre, Pennsylvania, United States, 18840

RECRUITING

United States, Pennsylvania

US Digestive Health at Wyomissing

Wyomissing, Pennsylvania, United States, 19610

RECRUITING

United States, South Carolina

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

RECRUITING

United States, South Carolina

McLeod Health

Florence, South Carolina, United States, 29506

RECRUITING

United States, South Dakota

Circle Clinical Research

Pierre, South Dakota, United States, 57104

RECRUITING

United States, Tennessee

The Jackson Clinic, PA

Jackson, Tennessee, United States, 38305

RECRUITING

United States, Texas

Horizon Clinical Research Group

Houston, Texas, United States, 77008

RECRUITING

United States, Texas

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, United States, 75701

RECRUITING

United States, Wisconsin

Ascension Columbia St. Mary's Wisconsin

Milwaukee, Wisconsin, United States, 53211