Actively Recruiting

Age: 20Years - 80Years
All Genders
Healthy Volunteers
ID05557487

Taiwan Real-world Low-dose Computed Tomography Screening Behavior and Outcome Research for High-Risk Subjects Based on Health Promotion Administration Part A: Questionnaire Survey Part B: LDCT Screening Outcome and Management

Led by Gee-Chen Chang · Updated on 2025-09-10

6618

Participants Needed

7

Research Sites

156 weeks

Total Duration

On this page

Sponsors

G

Gee-Chen Chang

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lung cancer is the leading cause of death worldwide and in Taiwan, with a significant portion of cases occurring in lifelong never-smokers, especially among East Asian women. This research aims to study lung cancer screening using low-dose computed tomography (LDCT) in high-risk groups, including previous heavy smokers, people with a family history of lung cancer, and those with high-risk occupational or environmental exposures. The study focuses on acceptance rates of LDCT screening and the detection rates of lung cancer in these groups. Participants are divided into three groups: former heavy smokers aged 50 to 80 years who quit smoking more than 6 months but less than 15 years ago; first-degree relatives of lung cancer patients meeting specific age criteria; and individuals aged 50 to 80 years with high-risk exposures such as air-pollution-related jobs, significant cooking exposure without ventilation, or history of treated pulmonary tuberculosis. LDCT screening is performed with follow-up scans and diagnostic workups as needed based on Lung RADS categories and nodule characteristics. Additional tests include blood and urine markers and pulmonary function tests. Participants will complete detailed questionnaires followed by LDCT screening, with follow-up imaging at intervals determined by initial findings. Researchers will monitor screening acceptance and completeness, lung cancer detection rates, and other health markers over two years. Safety and ability to tolerate procedures are assessed, and study participation involves regular evaluations and data collection to understand lung cancer risk and screening outcomes in the Taiwanese population.

CONDITIONS

Brief Title

Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration

Who Can Participate

Age: 20Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Group 1: Previous heavy smokers aged 50 to 80 years with at least 20 pack-years smoking history and successful smoking cessation for more than 6 months but less than 15 years
  • Group 2: First-degree relatives of lung cancer patients aged over 50 years, or younger than 50 but older than the youngest lung cancer patient in the family at diagnosis
  • Group 3: Individuals aged 50 to 80 years with one or more high-risk factors: air-pollution exposed occupations for at least 10 years, cooking index ≥110 (based on frequency and years of frying cooking), cooking without ventilation for over 20 years, or history of pulmonary tuberculosis with completed treatment more than 5 years ago
Not Eligible

You will not qualify if you...

  • Previous history of lung cancer
  • Another malignancy within 5 years except cervical carcinoma in situ or non-melanomatous skin cancer
  • Unable to tolerate transthoracic procedures or thoracotomy
  • Chest CT performed within 18 months prior to study
  • Hemoptysis of unknown cause within one month
  • Unexplained weight loss over 6 kg within one year
  • Known pregnancy
  • Unable to understand or respond to the written questionnaire even with study team support

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 2 years

Participants undergo low-dose computed tomography (LDCT) scans and various laboratory tests to evaluate lung health and risk factors.

Initial LDCT screening and follow-up LDCT scans every 3 to 6 months as needed, plus periodic blood and pulmonary function tests

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored over time for lung cancer detection and outcomes based on their LDCT results and clinical findings.

Trial Site Locations

Total: 7 locations

1

Chung Shan Medical University

Taichung, Taiwan, Taiwan, 402

Actively Recruiting

2

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Actively Recruiting

3

Hualien Tzu Chi Hospital

Hualien City, Taiwan, 970473

Actively Recruiting

4

E-Da Hospital

Kaohsiung City, Taiwan

Not Yet Recruiting

5

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Actively Recruiting

6

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

Not Yet Recruiting

7

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

G

GeeChen Chang, MD. PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Lung Cancer CT Screening and Lung-RADS in a Tuberculosis-endemic Country: The Korean Lung Cancer Screening Project (K-LUCAS).

Hyungjin Kim, Hyae Young Kim, Jin Mo Goo...

https://pubmed.ncbi.nlm.nih.gov/32286195