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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Everest Detection, Inc.
Study ID
NCT06816121
Status
Recruiting
Apply to this trial

Conditions

  • Lung Cancers

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Non-Cancer Cohort
    Patients With No Lung Nodules at Initial Computed Tomography (CT) Scan or Stable, Non-Suspicious Nodules at Follow-Up CT Scans
  • Arm: Indeterminate Cohort
    Patients with indeterminate pulmonary nodules actively in follow-up
  • Arm: 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
  • Arm: "Other Cancer" Cohort
    Patients with a pathologic diagnosis of cancers highly associated with smoking

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site 101Oklahoma CityOklahoma73102-

Find similar trials in Oklahoma City, OK

By research site
Site 101· Oklahoma City, OK

Related Studies