Blood test to detect early lung cancer in high-risk heavy smokers
Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
This project will test whether a blood-based test can detect early, symptom-free lung cancer in current or former heavy smokers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Everest Detection, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT06816121 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood samples from four cohorts — people with confirmed lung cancer, people without cancer, people with indeterminate lung nodules, and people with other smoking-related cancers — to develop and validate a biomarker-based screening test. Samples are taken at enrollment and again at 12 and 24 months to train and validate predictive models and to observe longitudinal changes. The study links blood results with recent CT imaging and clinical outcomes to characterize test performance for nodules classified as benign, indeterminate, or suspicious. No therapeutic interventions are given because the goal is to establish whether the blood signature can reliably flag early, asymptomatic lung cancer in high-risk smokers.
Who should consider this trial
Good fit: Ideal candidates are current or former smokers aged 30–80 who can give informed consent, provide blood samples, and meet cohort-specific imaging or diagnostic criteria (recent CT without nodules, indeterminate nodules, confirmed/suspected lung cancer, or other smoking-related cancer).
Not a fit: People with a cancer diagnosis in the past 5 years, recent systemic cancer therapy, hematologic malignancies or active viral infections, or who are pregnant would be excluded and would not be eligible to benefit from this protocol.
Why it matters
Potential benefit: If successful, the test could enable earlier detection of lung cancer in heavy smokers and help target diagnostic scans to those at highest risk.
How similar studies have performed: Other liquid-biopsy and blood-biomarker efforts for lung cancer screening have shown promising signals in case-control studies but have not yet delivered a widely validated, population-level screening test.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oklahoma City, Oklahoma
- Site 101 — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: Everest Detection Clinical Operations
- Email: apclinops@everestdetection.com
- Phone: 786.542.2122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.