Lung CancersNCT06816121
Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
An observational study of Lung Cancers, run by Everest Detection, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancers
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both smokers that meet USPSTF criteria for annual LD-CT screening (age 50-80, smoked >20 pack years, quit <15yr ago if former smoker) to younger (>30 years) and lighter smokers (>10 pack years)
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Site 101
Oklahoma City, Oklahoma, 73102
About this study
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.
- Participants confirmed to have lung cancer
- Participants without cancer
- Participants with moderate risk of lung cancer (indeterminate)
- Participants confirmed to have other types of cancers linked to smoking
Read more
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
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 pathologically 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Discovery and Validation for Blood-Based Early Lung Cancer Detection in Heavy Smokers
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.
Measured: From enrollment to the end of the study observation period of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start17 Feb 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everest Detection, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816121
- Sponsor's protocol ID
- RAD-01
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to study-specific considerations and data use restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
- ClinicalTrials.gov ID
- NCT06816121
- Acronym / sponsor ID
- RAD-01
- Conditions
- Lung Cancers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Everest Detection, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Participants confirmed to have lung cancer
- Participants without cancer
- Participants with moderate risk of lung cancer (indeterminate)
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 pathologically 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both smokers that meet USPSTF criteria for annual LD-CT screening (age 50-80, smoked >20 pack years, quit <15yr ago if former smoker) to younger (>30 years) and lighter smokers (>10 pack years)
Key inclusion criteria (16 listed)
- Understands the study and can provide written informed consent
- Willing and able to provide a blood sample
- Age 30-80
- Current or former smoker
- Recent CT scan within 3 months AND
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to study-specific considerations and data use restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancers, run by Everest Detection, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Everest Detection Clinical Operations (786.542.2122, apclinops@everestdetection.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.