Specimen and Clinical Data Collection Plan for LDCT Screening Participants

What this Trial Is About

Lung cancer is a leading cause of cancer deaths globally and in Taiwan, with many cases occurring in people who have never smoked. This trial aims to improve lung cancer risk prediction by collecting detailed clinical data and biospecimens from participants undergoing low-dose computed tomography (LDCT) screening. The project plans a five-year, multi-center effort starting with a one-year pilot and then recruiting 12,000 participants. It will gather information on genetics, proteins, imaging, lifestyle, and environmental exposures. Participants will be grouped mainly as previous heavy smokers aged 50 to 74 with a significant smoking history, or as first-degree relatives of lung cancer patients within specified age ranges. Those who currently smoke must agree to join a smoking cessation program. The study involves collecting biospecimens such as blood, urine, and tissue, performing genomic and proteomic analyses, and completing detailed questionnaires. The data will be standardized using a Common Data Model to support future research and collaborations. Throughout the study, participants will undergo diagnostic tests including checking bilirubin, urinary heavy metals, CRP, tumor markers, pulmonary function tests, and questionnaires. The main outcome is the confirmed diagnosis of lung lesions based on histopathological or cytological examination over a 12-year period from suspicious imaging findings. The study includes safety exclusions and will monitor participants' health status closely, with total involvement lasting up to 12 years for outcome evaluation.

Specimen and Clinical Data Collection Plan for LDCT Screening Participants