LDCT Screening in Non-smokers in Taiwan

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02611570
• Other study ID #: AS-IRB-BM-15039
• Status: Active, not recruiting
• Start date: October 2014
• Est. completion date: July 2028

Study information

• Verified date: October 2023
• Source: Academia Sinica, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12000
• Est. completion date: July 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

1. Never smokers or have smoked less than 10 pack-years and quitted smoking over 15 years.

2. age from 55 to 75 years for subjects without lung cancer family history; age 50-75 years for subjects with lung cancer family history (age less than 50 but older than the age at diagnosis of the youngest lung cancer proband is also eligible)

3. Having at least one of the following conditions:

(1)with family history of lung cancer within 1st, 2nd or 3rd degree relatives (2)with exposure history of environmental tobacco smoke in workplace or in home (3)history of chronic lung disease (Tuberculosis or COPD) (4)the cooking index equal or over than 110 [cooking index = 2/7 x (days of cooking by pan frying, stir frying, or deep frying in one week) x (cooking years)] (5)cooking without using cooking ventilation

Exclusion Criteria:

1. with history of lung cancer, or with cancers except skin cancer or cervical carcinoma in situ in the past 5 years

2. can not accept invasive diagnostic procedure or surgery

3. have been examined by chest computed tomography in the past 18 months

4. have unexplained hemoptysis in one month

5. weight loss over than 6 kg with unexplained reason among one year

6. pregnant

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	E-Da Cancer Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Shuang-Ho Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Wan Fang Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan City

Sponsors (13)

Lead Sponsor

Collaborator

Academia Sinica, Taiwan

Chang Gung Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Ministry of Health and Welfare, Taiwan, National Health Research Institutes, Taiwan, National Taiwan University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan, Taiwan Lung Cancer Society, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 64 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of LDCT for lung cancer among non-smokers	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.	3 years
Secondary	Monitoring the occurrence of lung cancer	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	5 years
Secondary	Monitoring the recurrence 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	5 years