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

NCT ID: NCT06816121

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2029-06-30

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 Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Cancer Cohort

Patients With No Lung Nodules at Initial Computed Tomography (CT) Scan or Stable, Non-Suspicious Nodules at Follow-Up CT Scans

No interventions assigned to this group

Indeterminate Cohort

Patients with indeterminate pulmonary nodules actively in follow-up

No interventions assigned to this group

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

No interventions assigned to this group

"Other Cancer" Cohort

Patients with a pathologic diagnosis of cancers highly associated with smoking

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Everest Detection, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Everest Detection Clinical Operations

Role: CONTACT

apclinops@everestdetection.com

786.542.2122

Other Identifiers

RAD-01

Identifier Type: -

Identifier Source: org_study_id