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A Multimodal Liquid Biopsy-Based Assay as a Pre-Screening Test Before Low Dose CT Thorax (LDCT) to Streamline Lung Cancer Screening in High-Risk Individuals

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: t
View:

∙ 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

Locations
Other Locations
Singapore
National University Hospital Singapore
RECRUITING
Singapore
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 140
Treatments
Experimental: High-Risk Individuals Without Known Lung Cancer
High-risk individuals without a prior diagnosis of lung cancer undergo blood-based liquid biopsy testing followed by low-dose CT (LDCT) thorax screening as per the study protocol. Participants with positive liquid biopsy results and negative LDCT findings will be offered a study-funded CT-PET scan for further evaluation.
Experimental: Early-Stage Lung Cancer Patients (Stage I-II)
Participants with histologically confirmed early-stage lung cancer (Stage I-II) undergo blood collection for liquid biopsy testing to evaluate assay performance in early disease.
Experimental: Advanced-Stage Lung Cancer Patients (Stage III-IV)
Participants with histologically confirmed advanced-stage lung cancer (Stage III-IV) undergo blood collection for liquid biopsy testing to evaluate assay performance in advanced disease.
Related Therapeutic Areas
Sponsors
Collaborators: Gene Solutions
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov

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