Status:

RECRUITING

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Lead Sponsor:

Freenome Holdings Inc.

Conditions:

Lung Cancer Diagnosis

Eligibility:

All Genders

50+ years

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 wh...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

November 28 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 15 2027

Estimated Enrollment :

20000 Patients enrolled

Trial Details

Trial ID

NCT06122077

Start Date

November 28 2023

End Date

June 15 2027

Last Update

August 5 2025

Active Locations (36)

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Page 1 of 9 (36 locations)

1

Science 37

Los Angeles, California, United States, 90230

2

Stamford Hospital

Stamford, Connecticut, United States, 06902

3

Hillcrest Medical Research

DeLand, Florida, United States, 32720

4

Universal Axon Clinical Research

Doral, Florida, United States, 33166

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening | DecenTrialz