NCT07048236Recruiting
Specimen and Clinical Data Collection Plan for LDCT Screening Participants
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12000 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 17 Jul 2025
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Chung Shan Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07048236
What you commit to
- Study type: Observational
- Planned participants: 12000
- From 17 Jul 2025 to the primary completion date, 30 Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of lung cancer
- Inability to undergo thoracic biopsy or surgery
Other illness
- History of chest computed tomography (including low-dose CT) within the past 12 months.
Other
- Pregnancy
- 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
Who the study is looking for
- 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.
Age in the registry: 20 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ministry of Health and Welfare Shuang-Ho Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| Chung Shan Medical University Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.