NCT06816121Recruiting
Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 17 Feb 2025
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Everest Detection, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT06816121
What you commit to
- Study type: Observational
- Planned participants: 350
- From 17 Feb 2025 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic therapy, radiation, or surgery for cancer within 1 year prior to enrollment
Other illness
- Cancer diagnosis within the last 5 years
- Any history of hematologic malignancies or myelodysplasia
- Known infection with HIV, HCV, or HBV
Other
- Active pregnancy
Who the study is looking for
- 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
Age in the registry: 30 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.