Specimen and Clinical Data Collection Plan for LDCT Screening Participants

Recruiting

• Conditions: Lung Cancer; Smoking; Family Relations

• Registration Number: NCT07048236
• Lead Sponsor: Chung Shan Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-07-15
• Study Start: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2029-12-30
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definitive diagnosis of lung lesions confirmed by histopathological or cytological examination.	Measured from time of suspicious imaging finding to histopathological or cytological diagnosis, within a 12 years period

Trial Locations

Locations (2)

Ministry of Health and Welfare Shuang-Ho Hospital; 🇨🇳 New Taipei City, Taiwan

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan