Lung Cancer Clinical Trial

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

20000

Study ID:

NCT06122077

Recruitment Status:

Recruiting

Sponsor:

Freenome Holdings Inc.

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There are 19 Locations for this study

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Science 37
Los Angeles California, 90230, United States More Info
Study Coordinator
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Hillcrest Medical Research
DeLand Florida, 32720, United States More Info
Study Coordinator
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Universal Axon Clinical Research
Doral Florida, 33166, United States More Info
Study Coordinator
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I.H.S Health, LLC
Kissimmee Florida, 34741, United States
SpeciCare, Inc
Gainesville Georgia, 30501, United States
Walgreens
Deerfield Illinois, 60015, United States
Advocate Lutheran Hospital, Advocate Aurora Research Institute
Park Ridge Illinois, 60068, United States More Info
Study Coordinator
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Springfield Clinic, LLP
Springfield Illinois, 62702, United States
Aton Health
Leawood Kansas, 66211, United States More Info
Study Coordinator
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Aton- Ascentist Healthcare
Lee's Summit Missouri, 64806, United States More Info
Study Coordinator
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Renown Regional Medical Center
Reno Nevada, 89502, United States More Info
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Wakemed
Raleigh North Carolina, 27610, United States More Info
Study Coordinator
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Altru Health System
Grand Forks North Dakota, 58201, United States More Info
Study Coordinator
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Oregon Health & Science University
Portland Oregon, 97201, United States More Info
Study Coordinator
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US Digestive Health at Lancaster
Lancaster Pennsylvania, 17601, United States More Info
Study Coordinator
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Guthrie Medical Group
Sayre Pennsylvania, 18840, United States More Info
Study Coordinator
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US Digestive Health at Wyomissing
Wyomissing Pennsylvania, 19610, United States More Info
Study Coordinator
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Medical University of South Carolina (MUSC)
Charleston South Carolina, 29425, United States More Info
Study Coordinator
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Advocate Health Aurora
Milwaukee Wisconsin, 53209, United States More Info
Study Coordinator
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

20000

Study ID:

NCT06122077

Recruitment Status:

Recruiting

Sponsor:


Freenome Holdings Inc.

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