Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancers. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Site 101 — Oklahoma City
Identifiers
NCT: NCT06816121 · RAD-01