MedDataX Logo

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

NCT ID: NCT06122077

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-28

Study Completion Date

2027-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multi-Center Trial of the ProLung Test™

NCT01566682

Solitary Pulmonary Nodule Multiple Pulmonary Nodules
COMPLETED

Identification of a Plasma Proteomic Signature for Lung Cancer

NCT01752101

Precancerous Conditions Carcinoma
COMPLETED

Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

NCT03851445

Previously Treated Non-Small Cell Lung Cancer
RECRUITING PHASE2/PHASE3

A Study of Lung Cancer Screening in People With Unexplained Weight Loss

NCT06717334

Lung Cancer Screening
RECRUITING

Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

NCT03633006

Lung Cancer (Diagnosis)
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Diagnosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Freenome Holdings Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victoria Sumner

Role: STUDY_DIRECTOR

Freenome Holdings Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Science 37

Los Angeles, California, United States

Site Status RECRUITING

Stamford Hospital

Stamford, Connecticut, United States

Site Status RECRUITING

Hillcrest Medical Research

DeLand, Florida, United States

Site Status RECRUITING

Universal Axon Clinical Research

Doral, Florida, United States

Site Status RECRUITING

I.H.S Health, LLC

Kissimmee, Florida, United States

Site Status RECRUITING

United Medical Research

Port Orange, Florida, United States

Site Status RECRUITING

Charter Research

The Villages, Florida, United States

Site Status RECRUITING

Charter Research

Winter Park, Florida, United States

Site Status RECRUITING

SpeciCare, Inc

Gainesville, Georgia, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Walgreens

Deerfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic, LLP

Springfield, Illinois, United States

Site Status RECRUITING

Aton Health

Leawood, Kansas, United States

Site Status RECRUITING

Ascension Via Christi Wichita

Wichita, Kansas, United States

Site Status RECRUITING

Ascension St. Agnes Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status RECRUITING

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

Site Status RECRUITING

Renown Regional Medical Center

Reno, Nevada, United States

Site Status RECRUITING

Inspira Medical Center

Mullica Hill, New Jersey, United States

Site Status RECRUITING

Our Lady of Lourdes Hospital

Binghamton, New York, United States

Site Status RECRUITING

Wakemed

Raleigh, North Carolina, United States

Site Status RECRUITING

Altru Health System

Grand Forks, North Dakota, United States

Site Status RECRUITING

Hightower Clinical

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Clinical Research Associates of Central PA

DuBois, Pennsylvania, United States

Site Status RECRUITING

US Digestive Health at Lancaster

Lancaster, Pennsylvania, United States

Site Status RECRUITING

Temple University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Guthrie Medical Group

Sayre, Pennsylvania, United States

Site Status RECRUITING

US Digestive Health at Wyomissing

Wyomissing, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status RECRUITING

McLeod Health

Florence, South Carolina, United States

Site Status RECRUITING

Circle Clinical Research

Pierre, South Dakota, United States

Site Status RECRUITING

The Jackson Clinic, PA

Jackson, Tennessee, United States

Site Status RECRUITING

Horizon Clinical Research Group

Houston, Texas, United States

Site Status RECRUITING

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, United States

Site Status RECRUITING

Ascension Columbia St. Mary's Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Harris Naemi, BS

Role: CONTACT

[email protected]
925-322-6486

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FRNM-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
NCT00077324 COMPLETED
Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
NCT07042867 NOT_YET_RECRUITING NA
Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
NCT04712877 RECRUITING
Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
NCT07062172 RECRUITING NA
A Feasibility Study to Further the Development of Lung Cancer-based Precision Medicine
NCT02597738 ACTIVE_NOT_RECRUITING NA
Liquid Biopsy for Early Non-small Lung Cancer Detection
NCT05462795 COMPLETED
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
NCT02715102 TERMINATED
Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway
NCT06387017 RECRUITING NA
Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
NCT01414595 COMPLETED
Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment
NCT05627674 ENROLLING_BY_INVITATION NA
Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study
NCT06105177 RECRUITING
Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
NCT03628638 COMPLETED
Lung Cancer Early Molecular Assessment Trial
NCT02894853 UNKNOWN
Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
NCT00512746 COMPLETED NA
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
NCT01958931 COMPLETED
Early Diagnosis of Pulmonary Nodules
NCT01752114 COMPLETED
Lung Screening Study
NCT00006382 COMPLETED NA
Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients
NCT00568282 COMPLETED
LcProt: Proteomics Longitudinal Cohort Study on Lung Cancer
NCT06778512 RECRUITING
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
NCT01700257 COMPLETED NA
CT Scans in Screening for Lung Cancer in Current and Former Smokers
NCT00625690 COMPLETED
S0424 - Carcinogens in Lung Tissue From Smokers (Closed to Entry as of 7/15/07) and Non-Smokers With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
NCT00450281 COMPLETED
LC-NMR Study Biomarkers to Detect Lung Cancer
NCT02024113 COMPLETED
A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
NCT07078032 NOT_YET_RECRUITING NA
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
NCT05384769 RECRUITING NA