NCT06816121 Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
| NCT ID | NCT06816121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Everest Detection, Inc. |
| Condition | Lung Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2025-02-17 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06816121 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Lung Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06816121 currently recruiting?
Yes, NCT06816121 is actively recruiting participants. Contact the research team at apclinops@everestdetection.com for enrollment information.
Where is the NCT06816121 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT06816121 clinical trial?
NCT06816121 is sponsored by Everest Detection, Inc.. The trial plans to enroll 350 participants.
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