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.

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Key information

Conditions

Lung Cancer Behavior Family Relations Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Thoracic Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung Shan Medical University, Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Pregnancy
History of chest computed tomography (including low-dose CT) within the past 12 months.
Previous diagnosis of lung cancer
Inability to undergo thoracic biopsy or surgery
Inability to complete the scan procedure, such as due to being unable to hold their breath.
Unexplained hemoptysis within the past month
Chest X-ray within the past month showing a clearly suspicious lung lesion
Unexplained weight loss exceeding 6 kilograms within the past year

Treatment and study plan

Specimen and clinical data collection

Diagnostic Test

Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire

Primary outcomes

Definitive diagnosis of lung lesions confirmed by histopathological or cytological examination.

Time frame: Measured from time of suspicious imaging finding to histopathological or cytological diagnosis, within a 12 years period

Study contacts

Contact information is provided by the study sponsor or research team.

GeeChen Chang, MD. PhD

CONTACT

[email protected]

+886-4-24739595 ext. 34414

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

Ministry of Health and Welfare
National Health Research Institutes, Taiwan

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2034
First posted: Jul 2, 2025
Registry last updated: Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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