NCT06816121

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Everest Detection, Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Lung Cancers

Timeline

• Start date: 2025-02-17
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2025-02-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States