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1. Non-smoking subjects with lung cancer family history
2. Non-smoking subjects with a given lung cancer risk other than lung cancer family history

LDCT at enrollment, annually for two years and biennially for 6 years if no lung cancer is detected

LDCT

Pan-Chyr Yang, M.D., Ph.D.

This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or have high risk exposures to lung cancer will be recruited to participate LDCT screening and followed up for their possible occurrence of lung cancer.

Lung cancer ranks the No. 1 lethal cancer in Taiwan, with a five-year survival rate (5-yr SR) of only 15%. Most of the patients with early lung cancer are asymptomatic, while 75% of patients with cancer-related symptom at diagnosis have local or distant metastasis. Compared to a 5-yr SR of 70-90% in stage I/II lung cancer, the 5-yr SR in late stage IIIb/IV is less than 15%. Despite the progress in pharmaceutical treatment for late stage disease, early detection is still the only way to improve the outcome and even cure of this potentially lethal disease. Low dose computed tomography (LDCT) in recognized as the best tool available for early diagnosis of lung cancer. However, the radiation exposure, high cost and high false-positive rate are the major concerns to adapt this detection tool to general population. Recent studies from Europe and US have shown that LDCT screening in high-risk cigarette smoking population can effectively reduce lung cancer mortality. However, the major type of lung cancer in Taiwan is adenocarcinoma, which commonly occurs in non-smoker. Therefore, the risk prediction model generated from studies of western countries may not be suitable for directly adapted to our country. LDCT screening for lung cancer detection in non-smoker remains a controversial issue worldwide, including Taiwan. Facing the unmet need, it is urgent to establish the risk assessment model to predict lung cancer risks in non-smokers and to evaluate the efficacy of LDCT screening in non-smoker high-risk population. In this study, we plan to enroll 12000 non-smoker subjects with a given lung cancer risk; half of them should have lung cancer family history. Each participant will receive LDCT at baseline, annually for two years, and biennially for 6 years. Our overall goal is to establish a risk assessment model of lung cancer in non-smokers and provide suggestions to government for considerations for lung cancer prevention and screening policy in Taiwan.

There are three specific aims in our proposed study:

Aim 1: To evaluate the risk assessment model for predicting lung cancer in non-smokers According to the results of LDCT screening, we expect to improve the risk prediction model for nonsmoker female established by GELAC study. The revised risk model will help recognizing higher risk population.

Aim 2: To establish the protocol for LDCT screening pilot study in Taiwan Establishing working protocol and procedures of LDCT screening to assure a homogeneous behavior among study sites

Aim 3: To establish the efficacy of LDCT screening for lung cancer in non-smoker Lung cancer detection rate, false-positive rate, and cost-effectiveness analysis of LDCT screening for non-smoker lung cancer in Taiwan will be established.

LDCT Screening in Non-smokers in Taiwan

Low Dose Computed Tomography Screening Study in Non-smokers With Risk Factors for Lung Cancer in Taiwan

True positive, false positive, true negative and false negative rates of LDCT on lung cancer screening. Each subject who is recognized as high risk to lung cancer will be recruited between 2014-2016.

Subjects who are recruited between 2014-2016 in this study will be followed every 3-12 months according to their nodule(s) discovered by LDCT for 5 years to obtain their potential occurrence of lung cancer

Subjects who have been diagnosed as lung cancer in this study will be monitored for their potential recurrence of lung cancer after clinical treatments/surgery by 5 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LDCT Screening in Non-smokers in Taiwan	NCT02611570	Lung Cancer	LDCT	- 75 Years	Academia Sinica, Taiwan
LDCT Screening in Non-smokers in Taiwan	NCT02611570	Lung Cancer	LDCT	- 75 Years	Academia Sinica, Taiwan

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