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Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers

Recruitingn/aAges 30 Years - 80 YearsAllEverest Detection, Inc.
NCT06816121 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Partici

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📋 Eligibility rules (as published)
Inclusion Criteria: All Participants: * Understands the study and can provide written informed consent * Willing and able to provide a blood sample * Age 30-80 * Current or former smoker Non-Cancer Cohort: * Recent CT scan within 3 months AND * No lung nodules (Lung-RADS 1) or benign/stable nodules Indeterminate Cohort: * Recent CT scan within 12 months AND * Indeterminate lung nodules under active monitoring Highly Suspicious or Confirmed Lung Cancer Cohort: * Confirmed untreated lung cancer OR * Highly suspicious lung nodules undergoing diagnostic work-up Other Cancer Cohort: \- Confirmed, untreated cancer associated with smoking Exclusion Criteria: * 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 * Active pregnancy
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What it tests

  • Not listed
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Where

1 site
Site 101
Oklahoma City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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