Lung CancerNCT07048236
Specimen and Clinical Data Collection Plan for LDCT Screening Participants
An observational study of Lung Cancer and Smoking, run by Chung Shan Medical University at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Smoking, Family Relations
- What is being tested?
- Specimen and clinical data collection
- How many people
- 12,000 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Jul 2025to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: High risk population for lung cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City
Po-Hao Feng, MD PhD
- Recruiting
Chung Shan Medical University
Taichung, Taiwan, 402
GEECHEN CHANG, MD, PhD, +886-4-2473959 ext. 34414, geechen@gmail.com
About this study
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
- Being tested
- Specimen and clinical data collection
- Keywords
- lung cancer, Low-dose computed tomography, Lung cancer family history, Smoking, proteomic, genomic, Lung cancer risk questionnaire
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen and clinical data collectionDiagnostic test
Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Specimen and clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitive diagnosis of lung lesions confirmed by histopathological or cytological examination.
Measured: Measured from time of suspicious imaging finding to histopathological or cytological diagnosis, within a 12 years period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start17 Jul 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Ministry of Health and Welfare
- Responsible party
- Principal investigator, Gee-Chen Chang, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048236
- Sponsor's protocol ID
- CS1-25029
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen and Clinical Data Collection Plan for LDCT Screening Participants
- ClinicalTrials.gov ID
- NCT07048236
- Acronym / sponsor ID
- CS1-25029
- Conditions
- Lung Cancer, Smoking, Family Relations
- Keywords
- lung cancer, Low-dose computed tomography, Lung cancer family history, Smoking, proteomic, genomic, Lung cancer risk questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Ministry of Health and Welfare
- Study start
- 17 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous heavy smokers | – | Diagnostic Test: Specimen and clinical data collectionAccording 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 | – | Diagnostic Test: Specimen and clinical data collectionAccording 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. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- High risk population for lung cancer
Key inclusion criteria (6 listed)
- Previous heavy smokers
- 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
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen and clinical data collectionCheck total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire | Diagnostic test | First degree relatives of lung cancer patients, Previous heavy smokers |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Smoking, run by Chung Shan Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GeeChen Chang, MD. PhD (+886-4-24739595 ext. 34414, geechen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.