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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 48 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is developing a blood test to find early lung cancer in heavy smokers who have no symptoms. It includes current or former smokers ages 30–80 with different cancer risks or diagnoses. Participants give blood at the start and at 12 and 24 months; test results are not shared with them or their doctors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 30–80 and a current or former smoker.
  • Can understand the study and give written consent to join.
  • Willing and able to give a blood sample.
  • No-cancer group: a CT scan within 3 months shows no lung nodules (small spots), or spots that are not cancer or have not changed.
  • Uncertain-risk group: a CT scan within 12 months shows lung spots of unclear cause that are being watched.
  • Lung cancer group: confirmed lung cancer that has not been treated, or lung spots strongly suspected to be cancer that are being tested.
  • Other-cancer group: confirmed cancer linked to smoking that has not been treated.

Who can't join

  • A cancer diagnosis within the past 5 years. The listing does not explain how this applies to the cancer groups.
  • Cancer treatment within the year before joining, including medicines that work throughout the body, radiation, or surgery.
  • Any history of blood cancer or myelodysplasia, a condition where bone marrow makes abnormal blood cells.
  • Known HIV, hepatitis C, or hepatitis B infection.
  • Currently pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

OK