LDCT Screening in Non-smokers in Taiwan

NCT02611570 | Active Not Recruiting DMC

• 1 other identifier: AS-IRB-BM-15039
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Lung Cancer

Keywords

Lung cancer; Low dose computed tomography; Screening; Non-smoker; Gender issue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Monitoring the occurrence of lung cancer

  5 years

• Monitoring the recurrence of lung cancer

  5 years

Study Arms (1)

Non-smokers at risk for lung cancer

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

Other: LDCT

Interventions

LDCT OTHER

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

Non-smokers at risk for lung cancer

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High risk population for lung cancer

You may qualify if:

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

You may not qualify if:

• with history of lung cancer, or with cancers except skin cancer or cervical carcinoma in situ in the past 5 years
• can not accept invasive diagnostic procedure or surgery
• have been examined by chest computed tomography in the past 18 months
• have unexplained hemoptysis in one month
• weight loss over than 6 kg with unexplained reason among one year
• pregnant

Sponsors & Collaborators

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

Study Sites (17)

Chiayi Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

Location

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Location

Shuang-Ho Hospital

New Taipei City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Wan Fang Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, 33001, Taiwan

Location

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• Hsiung CA, Lan Q, Hong YC, Chen CJ, Hosgood HD, Chang IS, Chatterjee N, Brennan P, Wu C, Zheng W, Chang GC, Wu T, Park JY, Hsiao CF, Kim YH, Shen H, Seow A, Yeager M, Tsai YH, Kim YT, Chow WH, Guo H, Wang WC, Sung SW, Hu Z, Chen KY, Kim JH, Chen Y, Huang L, Lee KM, Lo YL, Gao YT, Kim JH, Liu L, Huang MS, Jung TH, Jin G, Caporaso N, Yu D, Kim CH, Su WC, Shu XO, Xu P, Kim IS, Chen YM, Ma H, Shen M, Cha SI, Tan W, Chang CH, Sung JS, Zhang M, Yang TY, Park KH, Yuenger J, Wang CL, Ryu JS, Xiang Y, Deng Q, Hutchinson A, Kim JS, Cai Q, Landi MT, Yu CJ, Park JY, Tucker M, Hung JY, Lin CC, Perng RP, Boffetta P, Chen CY, Chen KC, Yang SY, Hu CY, Chang CK, Fraumeni JF Jr, Chanock S, Yang PC, Rothman N, Lin D. The 5p15.33 locus is associated with risk of lung adenocarcinoma in never-smoking females in Asia. PLoS Genet. 2010 Aug 5;6(8):e1001051. doi: 10.1371/journal.pgen.1001051.

  PMID: 20700438 BACKGROUND

• Wu X, Wang L, Ye Y, Aakre JA, Pu X, Chang GC, Yang PC, Roth JA, Marks RS, Lippman SM, Chang JY, Lu C, Deschamps C, Su WC, Wang WC, Huang MS, Chang DW, Li Y, Pankratz VS, Minna JD, Hong WK, Hildebrandt MA, Hsiung CA, Yang P. Genome-wide association study of genetic predictors of overall survival for non-small cell lung cancer in never smokers. Cancer Res. 2013 Jul 1;73(13):4028-38. doi: 10.1158/0008-5472.CAN-12-4033. Epub 2013 May 23.

  PMID: 23704207 BACKGROUND

• Chang GC, Chiu CH, Yu CJ, Chang YC, Chang YH, Hsu KH, Wu YC, Chen CY, Hsu HH, Wu MT, Yang CT, Chong IW, Lin YC, Hsia TC, Lin MC, Su WC, Lin CB, Lee KY, Wei YF, Lan GY, Chan WP, Wang KL, Wu MH, Tsai HH, Chian CF, Lai RS, Shih JY, Wang CL, Hsu JS, Chen KC, Chen CK, Hsia JY, Peng CK, Tang EK, Hsu CL, Chou TY, Shen WC, Tsai YH, Tsai CM, Chen YM, Lee YC, Chen HY, Yu SL, Chen CJ, Wan YL, Hsiung CA, Yang PC; TALENT Investigators. Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study. Lancet Respir Med. 2024 Feb;12(2):141-152. doi: 10.1016/S2213-2600(23)00338-7. Epub 2023 Nov 29.

  PMID: 38042167 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples Urine samples

MeSH Terms

Conditions

Lung Neoplasms; Sexism

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Prejudice; Social Behavior; Behavior; Social Discrimination

Study Officials

• Pan-Chyr Yang, M.D., Ph.D.

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 23, 2015
• Study Start: October 1, 2014
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

TW (17)