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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 45 days
  • Procedures mentioned: Blood draws, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (36)

CA

CT

FL

GA

IL

KS

MA

MD

MS

NC

ND

NJ

NV

  • Renown Regional Medical Center · Reno, NV 89502Study Coordinator · Study contactMore trials in Reno

NY

OK

OR

PA

SC

SD

TN

TX

  • Horizon Clinical Research Group · Houston, TX 77008Study Coordinator · Study contactMore trials in Houston
  • CHRISTUS Trinity Mother Frances Health System · Tyler, TX 75701Study Coordinator · Study contactMore trials in Tyler

WI

  • Ascension Columbia St. Mary's Wisconsin · Milwaukee, WI 53211Study Coordinator · Study contactMore trials in Milwaukee