Specimen and Clinical Data Collection Plan for LDCT Screening Participants (CLEAR-LUNG)

July 15, 2025 updated by: Gee-Chen Chang, Chung Shan Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: GeeChen Chang, MD. PhD
  • Phone Number: 34414 +886-4-24739595
  • Email: geechen@gmail.com

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Ministry of Health and Welfare Shuang-Ho Hospital
        • Contact:
          • Po-Hao Feng, MD PhD
      • Taichung, Taiwan, 402
        • Recruiting
        • Chung Shan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

High risk population for lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire
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
Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, pulmonary function test,Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured from time of suspicious imaging finding to histopathological or cytological diagnosis, within a 12 years period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Collaborators

National Health Research Institutes, Taiwan
Ministry of Health and Welfare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 17, 2025

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

June 24, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Actual)

July 2, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1-25029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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