Recruiting

Blood Test

Sponsor:

Everest Detection, Inc.

Code:

NCT06816121

Conditions

Lung Cancers

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Study Details

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. 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

Study ID

NCT06816121

Start date

Feb 17, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 and Locations

Central contacts

Everest Detection Clinical Operations

786.542.2122apclinops@everestdetection.com

Locations

Site 101

Recruiting

Oklahoma City, Oklahoma, United States, 73102

More Information

Sponsor

Everest Detection, Inc.

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Everest Detection, Inc. on 2026-04-13.