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

NCT06816121 | Recruiting

• 1 other identifier: RAD-01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Participants confirmed to have lung cancer
2. 2.Participants without cancer
3. 3.Participants with moderate risk of lung cancer (indeterminate)
4. 4.Participants confirmed to have other types of cancers linked to smoking

Conditions

Lung Cancers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Everest Detection, Inc.: lead

Study Sites (1)

Site 101

Oklahoma City, Oklahoma, 73102, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat samples derived from whole blood collection

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Everest Detection Clinical Operations

CONTACT

786.542.2122; apclinops@everestdetection.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)