Blood test to detect early lung cancer in high-risk heavy smokers
Official title: Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
Run by Everest Detection, Inc. · NCT06816121 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 30 Years to 80 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Everest Detection, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | February 17, 2025 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06816121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Site 101
Oklahoma City, Oklahoma, United States Recruiting
Study contacts
- Study coordinator: Everest Detection Clinical Operations
- Email: apclinops@everestdetection.com
- Phone: 786.542.2122
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.