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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancers

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Everest Detection Clinical Operations; Phone Number: 786.542.2122; Email: apclinops@everestdetection.com

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Recruiting
      • Site 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Non-Cancer Cohort; Patients With No Lung Nodules at Initial Computed Tomography (CT) Scan or Stable, Non-Suspicious Nodules at Follow-Up CT Scans
Indeterminate Cohort; Patients with indeterminate pulmonary nodules actively in follow-up
Highly Suspicious or Confirmed Lung Cancer Cohort; Patients with pathologic diagnosed, untreated lung cancer or highly suspicious for lung cancer that are still in workup
"Other Cancer" Cohort; Patients with a pathologic diagnosis of cancers highly associated with smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of the study observation period of 24 months

Collaborators and Investigators

• Sponsor: Everest Detection, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RAD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to study-specific considerations and data use restrictions.