Specimen and Clinical Data Collection Plan for LDCT Screening Participants

Lung cancer remains the leading cause of cancer-related mortality in Taiwan and globally, with increasing incidence and the highest healthcare cost burden among cancers in Taiwan. Despite the widespread use of low-dose computed tomography (LDCT) for screening smokers, over half of lung cancer cases in Taiwan occur in never-smokers, highlighting the need for improved risk stratification. Current national LDCT screening programs do not collect comprehensive risk-related data, limiting their predictive accuracy. This project proposes a five-year, multi-center initiative to establish an integrated biospecimen and clinical data collection system. In its first year, a feasibility pilot will be conducted, followed by recruitment of 12,000 participants. Data collection will include biospecimens (blood, urine, tissue), genomic and proteomic analyses, imaging, and detailed questionnaires covering lifestyle, environmental, and occupational exposures. The project will also develop and validate lung cancer prediction models incorporating epidemiologic, biomarker, air pollution, and imaging data. A Common Data Model (CDM) will be implemented to ensure cross-institutional data standardization and support future international collaboration.

NCT Number	NCT07048236
Lead Sponsor	Chung Shan Medical University Collaborators: National Health Research Institutes, Taiwan, Ministry of Health and Welfare
Conditions	Lung Cancer, Smoking, Family Relations
Enrollment	12,000 participants
Start Date	2025-07-17
Primary Completion	2029-12-30 (estimated)
Study Completion	2034-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-18