Recruiting

NCT Number: NCT06816121

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.

Recruiting

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 101

Oklahoma City, Oklahoma, 73102, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Biomarker Discovery and Validation for Blood-Based Early Lung Cancer Detection in Heavy Smokers

Time frame: From enrollment to the end of the study observation period of 24 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Everest Detection Clinical Operations

CONTACT

[email protected]

786.542.2122

Sponsors and collaborators

Lead sponsor

Everest Detection, Inc.

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Feb 10, 2025
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting