Specimen and Clinical Data Collection Plan for LDCT Screening Participants

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 74
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Taiwan
Ministry of Health and Welfare Shuang-Ho Hospital
RECRUITING
New Taipei City
Chung Shan Medical University
RECRUITING
Taichung
Contact Information
Primary
GeeChen Chang, MD. PhD
geechen@gmail.com
+886-4-24739595
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 12000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health and Welfare, National Health Research Institutes, Taiwan
Leads: Chung Shan Medical University

This content was sourced from clinicaltrials.gov