Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals

Summary

This study evaluates the feasibility and cost-effectiveness of using a blood-based liquid biopsy assay as a pre-screening tool before low-dose CT (LDCT) for lung cancer screening. By identifying individuals unlikely to have lung cancer, this approach aims to reduce unnecessary LDCT scans, radiation exposure, and healthcare costs, while improving early detection, particularly among high-risk individuals including never-smokers with a family history of lung cancer.

Eligibility

Inclusion Criteria

High-Risk Individuals (n = 100)

* No prior history of lung cancer
* Meets one of the following high-risk definitions:

  * Current or former smoker (quit within the past 15 years), aged 55-74 years, with a smoking history of ≥30 pack-years; OR
  * Never-smoker aged 55-75 years with a first-degree family history of lung cancer
* Able and willing to provide written informed consent

Early-Stage Lung Cancer Patients (n = 20)

* Aged ≥21 years
* Histologically or clinically confirmed stage I-II lung cancer
* Treatment-naïve (no prior surgery, chemotherapy, radiotherapy, or immunotherapy for lung cancer)
* Able and willing to provide written informed consent

Advanced-Stage Lung Cancer Patients (n = 20)

* Aged ≥21 years
* Histologically or clinically confirmed stage III-IV lung cancer
* Treatment-naïve (no prior systemic or local therapy for lung cancer)
* Able and willing to provide written informed consent

Exclusion Criteria

Applicable to All Participants

* Pregnant or breastfeeding women
* Inability or unwillingness to comply with study procedures

High-Risk Individuals Only

* Known allergy or contraindication to CT contrast agents
* Prior low-dose CT (LDCT), CT thorax, or PET-CT performed within 12 months prior to enrollment

Lung Cancer Cohorts Only

• Receipt of any prior cancer-directed treatment for lung cancer

Conditions6

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