Collecting biospecimens and health data from people having low-dose CT lung screening

Specimen and Clinical Data Collection Plan for LDCT Screening Participants

This project will collect blood, urine, tissue, imaging, and questionnaire data from people getting LDCT lung screening to try to improve how well we predict who will develop lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 12000 (estimated)
• Ages: 20 Years to 74 Years
• Sex: All
• Sponsor: Chung Shan Medical University (other)
• Locations: 2 sites (Taichung, Taiwan and 1 other locations)
• Trial ID: NCT07048236 on ClinicalTrials.gov

What this trial studies

This five-year, multi-center initiative will build an integrated biospecimen and clinical data repository linked to LDCT screening programs. The first year is a feasibility pilot, followed by recruitment of up to 12,000 participants across participating hospitals. Collected materials will include blood, urine, and tissue samples, genomic and proteomic analyses, imaging, and detailed lifestyle, environmental, and occupational questionnaires. The assembled data set will be used to develop and validate improved risk-stratification tools to refine screening and early-detection approaches.

Who should consider this trial

Good fit: Ideal candidates are adults who meet Taiwan's LDCT screening criteria — heavy smokers aged 50–74 with ≥20 pack-years or first-degree relatives of lung cancer patients (men 45–74, women 40–74) who can undergo LDCT and provide biospecimens, with current smokers agreeing to a cessation program.

Not a fit: People who are pregnant, have had a chest CT within the past 12 months, have a prior lung cancer diagnosis, or cannot complete imaging or tissue sampling procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the project could lead to better identification of people at high risk for lung cancer and more personalized screening strategies that catch cancer earlier.

How similar studies have performed: LDCT screening has proven mortality benefits in high-risk smokers, while biomarker and proteomic approaches for improving screening risk models are promising but remain under active research and not yet widely validated.

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

Where this trial is running

Taichung, Taiwan and 1 other locations

• Chung Shan Medical University — Taichung, Taiwan, Taiwan (RECRUITING)
• Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City, Taiwan (RECRUITING)

Study contacts

• Study coordinator: GeeChen Chang, MD. PhD

Conditions: Lung Cancer, Smoking, Family Relations, lung cancer, Low-dose computed tomography, Lung cancer family history, proteomic, genomic