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RECRUITING
NCT05572944

Formatting the Risk Prediction Models for Never-Smoking Lung Cancer

Sponsor: Chung Shan Medical University

View on ClinicalTrials.gov

Summary

Lung Cancer is the leading cause of cancer-related deaths in Taiwan and worldwide and the incidence is also increasing. The payment for lung cancer which occupies the largest part of National Health Insurance expense is over 15 billion in 2018. Because about 80% lung cancer patients are smokers in western countries the low-dose computed tomography screening focuses on the smoking population It is quite different in South-East Asia particularly in Taiwan that 53% of Taiwan lung cancer are never-smokers and the etiology and the underlying mechanisms are still unknown. The preliminary results of prospective TALENT study indicated that family history plays a key role in tumorigenesis of Taiwan lung cancers but several important variables such as air pollution, biomarkers, radiomics analysis are not available limits the accuracy of lung cancer identification. Hence, it is critical to integrate most of factors involved in lung cancer formation into a multidimensional lung cancer prediction model which could benefit never-smoker lung cancers in Taiwan and East Asia even in the western countries. The investigators initiate a clinical study to validate the multidimensional lung cancer prediction model for never-smoking population by multicenter prospective study.

Official title: Validation and Optimization of Multidimensional Modelling for Never Smoking Lung Cancer Risk Prediction by Multicenter Prospective Study

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2022-12-15

Completion Date

2029-12-31

Last Updated

2026-02-17

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

LDCT lung cancer screen, immediately

Participants will receive the following things in sequence 1. Non-smoker lung cancer prediction model among Taiwanese population by questionnaire 2. Check autoantibodies against p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4 and SOX2 in the blood of recruited patients and detect 133 SNPs and 11 mitochondrial mutations which are highly correlated with never-smoking lung cancer in our preliminary data 3. Check total bilirubin, urinary heavy metals, serum tumor marker, including CEA, alpha-fetal protein, etc. 4. Check pulmonary function test and chest X ray 5. Arrenge chest CT right away, and detection, classification, prediction of lung cancer risk in CT using deep learning and radiomics 6. Optimization and validation of lung cancer risk and probability prediction model: prospective multicenter clinical study.

OTHER

LDCT lung cancer screen, later

Participants will receive the following things in sequence 1. Non-smoker lung cancer prediction model among Taiwanese population by questionnaire 2. Check autoantibodies against p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4 and SOX2 in the blood of recruited patients and detect 133 SNPs and 11 mitochondrial mutations which are highly correlated with never-smoking lung cancer in our preliminary data 3. Check total bilirubin, urinary heavy metals, serum tumor marker, including CEA, alpha-fetal protein, etc. 4. Check pulmonary function test. 5. Arrange AI-asisted chest X-ray right away. 6. Arrange chest CT three years later, and detection, classification, prediction of lung cancer risk in CT using deep learning and radiomics 7. Optimization and validation of lung cancer risk and probability prediction model: prospective multicenter clinical study.

Locations (7)

Chung Shan Medical University Hospital

Taichung, Taiwan, Taiwan

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Hualien Tzu Chi Hospital

Hualien City, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan