NCT07048236 Specimen and Clinical Data Collection Plan for LDCT Screening Participants
| NCT ID | NCT07048236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chung Shan Medical University |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2029-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,000 participants in total. It began in 2025-07-17 with a primary completion date of 2029-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07048236 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 74 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07048236 currently recruiting?
Yes, NCT07048236 is actively recruiting participants. Contact the research team at geechen@gmail.com for enrollment information.
Where is the NCT07048236 trial being conducted?
This trial is being conducted at Taichung, Taiwan, New Taipei City, Taiwan.
Who is sponsoring the NCT07048236 clinical trial?
NCT07048236 is sponsored by Chung Shan Medical University. The trial plans to enroll 12,000 participants.
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