Lung Cancer Screening in Population Who Had Never Smoked

January 26, 2026 updated by: Gee-Chen Chang, Chung Shan Medical University

Lung Cancer Screening in Population Who Had Never Smoked and the Validation of Lung Cancer Risk Prediction Model

Study design: prospective, single arm.

Objectives: survey lung cancer detection rate of low-dose computed tomography (LDCT) screening in individuals who had never smoked.

Participants will undergo questionnaires, and collecting specimens including blood, urine, and medical informations including results of pulmonary function tests, and LDCT screening upon inclusion. The participants will be followed up according to current standards of clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer remains the leading cause of cancer-related mortality worldwide, with a particularly high incidence and mortality rate in Taiwan. Notably, over half of lung cancer cases in Taiwan occur among individuals who have never smoked, a pattern distinct from Western populations. In response to this unique epidemiological profile, this project aims to promote community-based lung cancer screening among never-smokers and to validate the FORMOSA lung cancer risk prediction model, which integrates demographic, environmental, genetic, and clinical factors.

This prospective, single-arm, open-label study will recruit approximately 2,500 participants aged 40 to 80 years with no history of smoking, through hospital and community outreach. Eligible participants will provide informed consent and undergo comprehensive assessments, including questionnaires on lifestyle and environmental exposures, low-dose computed tomography (LDCT), chest X-ray, pulmonary function tests, and collection of blood and urine samples. LDCT results will be interpreted according to the modified ACR Lung-RADS v1.1 criteria. Biological specimens will be used for biomarker, heavy metal, genetic, and proteomic analyses. Participants with abnormal findings will be followed according to standard clinical protocols, and tissue samples from invasive procedures will be retained for further molecular studies.

The primary outcomes include the lung cancer detection rate among never-smoked participants and the validation metrics (sensitivity, specificity, positive and negative predictive values) of the FORMOSA lung cancer risk prediction model. Statistical analyses will employ descriptive statistics, Kaplan-Meier survival analysis, log-rank tests, Cox proportional hazards models, and group comparisons using ANOVA, Kruskal-Wallis, chi-square, Fisher's exact tests, and logistic-regression. Preliminary data suggest that the FORMOSA model can identify high-risk individuals with a lung cancer detection rate of 2.8-3.3%, significantly higher than the general population rate of 0.78%.

This project is expected to enhance early detection of lung cancer in never-smokers, improve public awareness, and establish a robust epidemiological database for Taiwan. The validation of the FORMOSA model will provide a scientific basis for refining screening strategies and inform future public health policies targeting high-risk, non-smoking populations. The study is conducted with strict adherence to ethical standards, ensuring participant rights and data security. Funding is provided by the Ministry of Health and Welfare's "Healthy Taiwan Deep Cultivation Plan." In summary, this research addresses a critical gap in lung cancer prevention by focusing on never-smokers, leveraging a comprehensive risk prediction model, and implementing a community-based screening approach. The anticipated outcomes will contribute significantly to reducing late-stage lung cancer diagnoses and mortality, and serve as a reference for future health policy development in Taiwan and similar populations.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

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: Gee-Chen Chang, MD, PhD.
  • Phone Number: 34414 886-4-24739595
  • Email: geechen@gmail.com

Study Contact Backup

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

Description

Inclusion Criteria:

  1. Individuals with no history of smoking.
  2. Aged 40 to 80 years.
  3. Willing to provide written informed consent and complete questionnaire assessments.
  4. After undergoing examinations, willing to provide relevant biological information, including but not limited to: blood samples, urine samples, pulmonary function test results, imaging data, and tissue specimens obtained from invasive biopsies or surgical procedures (if applicable).

Exclusion Criteria:

  1. History of lung cancer, or a diagnosis of any malignancy other than skin cancer or cervical carcinoma in situ within the past five years.
  2. Undergoing chest computed tomography (CT) scans within the past 18 months.
  3. Unexplained hemoptysis within the past one month.
  4. Unexplained weight loss exceeding 6 kilograms within the past one year.
  5. Pregnancy.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDCT screening arm
LDCT screening, lung function test, and specimens collections
Diagnostic test: Low dose computed tomography
Low dose computed tomography for lung cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer detection rate
Time Frame: 8 years of follow-up
The rate of lung cancer diagnosis during follow up periord.
8 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUROC of FORMOSA Lung Cancer Risk Prediction Model
Time Frame: 8 years
Assess the sensitivity, specificity, positive predicting value, negative predicting value, and ROC analysis of FORMOSA Lung Cancer Risk Prediction Model
8 years

Collaborators and Investigators

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

Sponsor

Chung Shan Medical University

Collaborators

Ministry of Health and Welfare, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1-26008

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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