Specimen and Clinical Data Collection Plan for LDCT Screening Participants

NCT07048236 | Recruiting

• 1 other identifier: CS1-25029
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Smoking; Family Relations

Keywords

lung cancer; Low-dose computed tomography; Lung cancer family history; Smoking; proteomic; genomic; Lung cancer risk questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: Specimen and clinical data collection

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.

Diagnostic Test: Specimen and clinical data collection

Interventions

Specimen and clinical data collection DIAGNOSTIC_TEST

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

First degree relatives of lung cancer patients; Previous heavy smokers

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High risk population for lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead
• National Health Research Institutes, Taiwan: collaborator
• Ministry of Health and Welfare: collaborator

Study Sites (2)

Chung Shan Medical University

Taichung, Taiwan, 402, Taiwan

RECRUITING

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, urine samples, lung tissue samples.

MeSH Terms

Conditions

Lung Neoplasms; Smoking

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

GeeChen Chang, MD. PhD

CONTACT

+886-4-24739595; geechen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Chung Shan Medical University

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)