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LDCT Screening in Non-smokers in Taiwan

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ClinicalTrials.gov Identifier: NCT02611570
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
Taiwan Lung Cancer Society
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chung Shan Medical University
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
China Medical University Hospital
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Pan-Chyr Yang, MD, PhD, Academia Sinica, Taiwan

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.

Condition or disease
Lung Cancer

Detailed 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. There are three specific aims in our proposed study and will be carried out in three phases. The first (pilot) phase (from 2014 to 2015, 14 months), aims to establish the LDCT screening protocol and risk assessment model for lung cancer prediction. 4500 subjects will be enrolled for first LDCT screening, preliminary result will be analyzed. The second phase (from 2016-2017, 24 months) considers to perform follow up LDCT and enroll another 7500 subjects for LDCT screening and follow up. The fine tuning of LDCT screening protocol and risk assessment model will be performed. The third phase (from 2018-2019, 24 months) is to complete the image and clinical follow up of all the subjects, the detection rate of lung cancer, false-positive rate, and cost-effectiveness analysis of LDCT screening for non-smoker lung cancer in Taiwan will be established.

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.


Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Low Dose Computed Tomography Screening Study in Non-smokers With Risk Factors for Lung Cancer in Taiwan
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
LDCT and follow-up
LDCT(1.5 mSV) at enrollment. If subjects with positive result of LDCT, then subjects will be under surgery, resection or followed by every 3-12 months for their possible occurrence of lung cancer.The frequency of follow-up depends on their pathological status and changes of nodules.



Primary Outcome Measures :
  1. Validity of LDCT for lung cancer among non-smokers [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Monitoring the occurrence of lung cancer [ Time Frame: 5 years ]
    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

  2. Monitoring the recurrence of lung cancer [ Time Frame: 5 years ]
    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


Biospecimen Retention:   Samples With DNA
blood samples Urine samples


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
High risk population for lung cancer
Criteria

Inclusion Criteria:

Subjects who are

  1. Never smokers or have smoked less than 10 pack-years and quitted smoking over 15 years.
  2. 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 lung disease (Tuberculosis or COPD) (4)the index of cooking frequency over than or equal to 110 (index of cooking frequency= 2/7 x(days of using saute, fry, or deep-fried a week)x(cooking years) (5)cooked without using cooking hoods (6)age from 55 to 75 years-old (subjects who have family history of lung cancer and were older than index case in family can be recruited in even they are less than 55 years-old

Exclusion Criteria:

Subjects who will be excluded from our study with following conditions,

  1. with history of lung cancer, or with cancers except skin cancer or cervical carcinoma in situ in past 5 years
  2. can not accept thoracentesis or surgery
  3. have been examined by chest computed tomography in 18 months
  4. have unexplained Hemoptysis in one month
  5. weight loss over than 6 kg with unexplained reason among one year
  6. pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611570


Contacts
Contact: Pan-Chyr Yang, M.D., Ph.D. +886-2-33662000 pcyang@ntu.edu.tw
Contact: Chun-ming Tsai, M.D. +886-2-28757496 cmtsai@vghtpe.gov.tw

Locations
Taiwan
Chiayi Chang Gung Memorial Hospital Recruiting
Chiayi county, Taiwan, 61363
Principal Investigator: Ying-Huang Tsai, M.D.         
Sub-Investigator: Yu-San Liao, M.D.         
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 807
Principal Investigator: Inn-Wen Chong, M.D.         
Sub-Investigator: Reu-Sheng Sheu, M.D., Ph.D.         
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Principal Investigator: Ming-Ting Wu, M.D.         
Sub-Investigator: Ruey-Sheng Lai, M.D.         
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 83301
Principal Investigator: Meng-Chih Lin, M.D.         
Sub-Investigator: Sheung-Fat Ko, M.D.         
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan, 40201
Principal Investigator: Chih-Yi Chen, M.D.         
Sub-Investigator: Hao-Hung Tsai, M.D.         
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 404
Principal Investigator: Kun-San Chao, M.D.         
Sub-Investigator: Wei-Chih Shen, Ph.D.         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
Principal Investigator: Gee-Chen Chang, M.D., Ph.D.         
Sub-Investigator: Si-Wa Chan, M.D.         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 112
Principal Investigator: Pan-Chyr Yang, M.D., Ph.D.         
Sub-Investigator: Chong-Jen Yu, M.D., Ph.D.         
Sub-Investigator: Yuen-Chung Chang, M.D., Ph.D.         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chao-hua Chiu, M.D.         
Principal Investigator: Chao-hua Chiu, M.D.         
Sub-Investigator: Chun-ming Tsai, M.D.         
Sub-Investigator: Yu-Chung Wu, M.D.         
Sub-Investigator: Mei-Han Wu, M.D.         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Principal Investigator: Chih-Feng Chian, M.D.         
Principal Investigator: Hsian-He Hsu, M.D.         
Linkou Chang Gung Memorial Hospital Recruiting
Taoyuan City, Taiwan, 33001
Principal Investigator: Yung-Liang Wan, M.D.         
Sub-Investigator: Cheng-Ta Yang, M.D.         
Sponsors and Collaborators
Academia Sinica, Taiwan
Taiwan Lung Cancer Society
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
Chung Shan Medical University
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
China Medical University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Pan-Chyr Yang, M.D., Ph.D. National Taiwan University

Publications:
Hosgood HD 3rd, Wang WC, Hong YC, Wang JC, Chen K, Chang IS, Chen CJ, Lu D, Yin Z, Wu C, Zheng W, Qian B, Park JY, Kim YH, Chatterjee N, Chen Y, Chang GC, Hsiao CF, Yeager M, Tsai YH, Wei H, Kim YT, Wu W, Zhao Z, Chow WH, Zhu X, Lo YL, Sung SW, Chen KY, Yuenger J, Kim JH, Huang L, Chen YH, Gao YT, Kim JH, Huang MS, Jung TH, Caporaso N, Zhao X, Huan Z, Yu D, Kim CH, Su WC, Shu XO, Kim IS, Bassig B, Chen YM, Cha SI, Tan W, Chen H, Yang TY, Sung JS, Wang CL, Li X, Park KH, Yu CJ, Ryu JS, Xiang Y, Hutchinson A, Kim JS, Cai Q, Landi MT, Lee KM, Hung JY, Park JY, Tucker M, Lin CC, Ren Y, Perng RP, Chen CY, Jin L, Chen KC, Li YJ, Chiu YF, Tsai FY, Yang PC, Fraumeni JF Jr, Seow A, Lin D, Zhou B, Chanock S, Hsiung CA, Rothman N, Lan Q. Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia. Hum Genet. 2012 Jul;131(7):1197-203. doi: 10.1007/s00439-012-1144-8. Epub 2012 Feb 25.
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). pii: e1001051. doi: 10.1371/journal.pgen.1001051.

Responsible Party: Pan-Chyr Yang, MD, PhD, Research Fellow, Academia Sinica, Taiwan
ClinicalTrials.gov Identifier: NCT02611570     History of Changes
Other Study ID Numbers: AS-IRB-BM-15039
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Pan-Chyr Yang, MD, PhD, Academia Sinica, Taiwan:
Lung cancer
Low dose computed tomography
Screening
Non-smoker
Gender issue

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases