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Validation of a blood test for early lung cancer detection

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

Observational Freenome Holdings Inc. · NCT06122077

This study is testing a new blood test to see if it can help detect lung cancer early in people who are at high risk.

Quick facts

Study typeObservational
Enrollment20000 (estimated)
Ages50 Years and up
SexAll
SponsorFreenome Holdings Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations36 sites (Los Angeles, California and 35 other locations)
Trial IDNCT06122077 on ClinicalTrials.gov

What this trial studies

The PROACT LUNG study is a prospective multi-center observational study aimed at validating the Freenome Multiomics Blood Test for early lung cancer detection. Participants who are at high risk will provide blood samples while undergoing routine low-dose computed tomography (LDCT) screening. The study will collect demographic and clinical data, including medical history and exposure factors, to evaluate the test's performance. Participants will be followed for a minimum of 24 months to assess outcomes related to lung cancer diagnosis.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a significant smoking history who are undergoing routine lung cancer screening.

Not a fit: Patients currently undergoing cancer treatment or with a recent history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of lung cancer, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using blood-based tests for cancer detection, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung Cancer DiagnosisArtificial IntelligenceLiquid BiopsyBlood Test CancerCancer DiagnosticGenomicsGenomics TestMultiomics
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.