Specimen and Clinical Data Collection Plan for LDCT Screening Participants

Launched by CHUNG SHAN MEDICAL UNIVERSITY · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying ways to improve lung cancer screening, especially for people at higher risk because of smoking or family history. Lung cancer is a leading cause of death in Taiwan and worldwide, and while current screening uses low-dose CT scans to check smokers, many lung cancers happen in people who never smoked. This study aims to collect detailed health information, biological samples (like blood and urine), and imaging scans from 12,000 participants over five years. The goal is to create better tools to predict who might develop lung cancer by looking at a combination of lifestyle, genetic factors, environmental exposures, and scan results.

People who might join include adults aged 50 to 74 who have smoked heavily in the past or quit within the last 15 years and agree to try quitting if they still smoke. It also includes men and women aged 45 to 74 who have a close family member (like a parent, sibling, or child) diagnosed with lung cancer, with current smokers agreeing to a quitting program too. Participants will provide samples and answer questionnaires about their health and environment, as well as undergo lung scans. This study will help doctors better understand lung cancer risks and improve screening methods for the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Previous heavy smokers
• According to The Lung Cancer Early Detection Program in Taiwan:
• • Adults aged 50 to 74 years with a smoking history of at least 20 pack-years, who are either current smokers or have quit smoking within the past 15 years. Current smokers must agree to participate in a smoking cessation program.
• • First-degree relatives of lung cancer patients
• According to The Lung Cancer Early Detection Program in Taiwan:
• • Men aged 45 to 74 years and women aged 40 to 74 years who have a biological parent, child, or sibling diagnosed with lung cancer. Individuals who currently smoke must agree to participate in a smoking cessation program.
• Exclusion Criteria:
• • 1. Pregnancy
• • 2. History of chest computed tomography (including low-dose CT) within the past 12 months.
• • 3. Previous diagnosis of lung cancer
• • 4. Inability to undergo thoracic biopsy or surgery
• • 5. Inability to complete the scan procedure, such as due to being unable to hold their breath.
• • 6. Unexplained hemoptysis within the past month
• • 7. Chest X-ray within the past month showing a clearly suspicious lung lesion
• • 8. Unexplained weight loss exceeding 6 kilograms within the past year