The goal of this observational study is to develop and evaluate a blood test for asymptomatic heavy smokers to screen for those at highest risk of developing lung cancer. The aim of this study is to develop, train, and validate a blood-based screening test designed to detect biomarkers associated with lung cancer. The study will utilize samples collected from 4 distinct cohorts.
1. Participants confirmed to have lung cancer 2. Participants without cancer 3. Participants with moderate risk of lung cancer (indeterminate) 4. Participants confirmed to have other types of cancers linked to smoking
The main question this study aims to answer is whether the blood test can detect existing early-stage lung cancer in heavy smokers without symptoms and to provide insights into device performance and long-term outcomes when scans show no nodules, benign findings, or indeterminate nodules.
Participants will provide blood samples at the start of the study and during follow-up visits at 12 and 24 months. Participants will share information about their smoking history, lung cancer status, and relevant medical history
Researchers will collect blood samples, process them, and analyze the biomarkers at the Everest Detection laboratory. No results will be shared with participants or their doctors. The study will run for about 48 months, including a 24-month enrollment period and 24 months of follow-up to track participants' health and lung cancer outcomes.
Understands the study and can provide written informed consent
Willing and able to provide a blood sample
Age 30-80
Current or former smoker
Cancer diagnosis within the last 5 years
Systemic therapy, radiation, or surgery for cancer within 1 year prior to enrollment
Any history of hematologic malignancies or myelodysplasia
Known infection with HIV, HCV, or HBV
Both smokers that meet USPSTF criteria for annual LD-CT screening (age 50-80, smoked \>20 pack years, quit \<15yr ago if former smoker) to younger (\>30 years) and lighter smokers (\>10 pack years)
Case-control
Prospective
Not listed
Biomarker Discovery and Validation for Blood-Based Early Lung Cancer Detection in Heavy Smokers
This study aims to discover and optimize biomarkers for a blood-based test that detects early-stage lung cancer in heavy smokers without symptoms. Researchers will develop and validate the test using blood samples from individuals with lung cancer, those at varying screening risk levels (Lung-RADS 1-4), and heavy smokers with smoking-related cancers.
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