Collecting biospecimens and health data from people having low-dose CT lung screening
Official title: Specimen and Clinical Data Collection Plan for LDCT Screening Participants
Run by Chung Shan Medical University · NCT07048236 · Data updated 2026-11-12
This project will collect blood, urine, tissue, imaging, and questionnaire data from people getting LDCT lung screening to try to improve how well we predict who will develop lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 74 Years |
| Sex | All |
| Enrollment | 12000 (estimated) |
| Sponsor | Chung Shan Medical University Academic / other |
| Locations | 2 sites (Taichung, Taiwan and 1 other locations) |
| Status | Recruiting |
| Started | July 17, 2025 |
| Main results expected | December 30, 2029 |
| Study ends | December 31, 2034 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT07048236 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who meet Taiwan's LDCT screening criteria — heavy smokers aged 50–74 with ≥20 pack-years or first-degree relatives of lung cancer patients (men 45–74, women 40–74) who can undergo LDCT and provide biospecimens, with current smokers agreeing to a cessation program.
✕Probably not a fit
People who are pregnant, have had a chest CT within the past 12 months, have a prior lung cancer diagnosis, or cannot complete imaging or tissue sampling procedures are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This five-year, multi-center initiative will build an integrated biospecimen and clinical data repository linked to LDCT screening programs. The first year is a feasibility pilot, followed by recruitment of up to 12,000 participants across participating hospitals. Collected materials will include blood, urine, and tissue samples, genomic and proteomic analyses, imaging, and detailed lifestyle, environmental, and occupational questionnaires. The assembled data set will be used to develop and validate improved risk-stratification tools to refine screening and early-detection approaches.
Why it matters
Potential benefit: If successful, the project could lead to better identification of people at high risk for lung cancer and more personalized screening strategies that catch cancer earlier.
How similar studies have gone: LDCT screening has proven mortality benefits in high-risk smokers, while biomarker and proteomic approaches for improving screening risk models are promising but remain under active research and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Chung Shan Medical University
Taichung, Taiwan, Taiwan Recruiting -
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan Recruiting
Study contacts
- Study coordinator: GeeChen Chang, MD. PhD
- Email: geechen@gmail.com
- Phone: +886-4-24739595
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.