Lung Cancer Screening in Population Who Had Never Smoked

NCT07383454 | Not Yet Recruiting DMC

• 1 other identifier: CS1-26008
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis); Non-Small Cell Lung Cancer; Small Cell Carcinoma of Lung; Screening Strategy

Keywords

Low dose computed tomography (LDCT); Lung cancer in individuals who had never smoked (LCINS); Lung cancer risk prediction model (LCRPM); Lung cancer; Non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Lung cancer detection rate

  The rate of lung cancer diagnosis during follow up periord.

  8 years of follow-up

Secondary Outcomes (1)

• AUROC of FORMOSA Lung Cancer Risk Prediction Model

  8 years

Study Arms (1)

LDCT screening arm

EXPERIMENTAL

LDCT screening, lung function test, and specimens collections

Diagnostic Test: Low dose computed tomography

Interventions

Low dose computed tomography DIAGNOSTIC_TEST

Low dose computed tomography for lung cancer screening

LDCT screening arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with no history of smoking.
• Aged 40 to 80 years.
• Willing to provide written informed consent and complete questionnaire assessments.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Chung Shan Medical University: lead
• Ministry of Health and Welfare, Taiwan: collaborator

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Related Links

• Related Info

MeSH Terms

Conditions

Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Gee-Chen Chang, MD, PhD.

CONTACT

886-4-24739595; geechen@gmail.com

Lung-Ying Huang, Mrs.

CONTACT

886-4-24739595; cshe1365@csh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2034
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share