Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration
NCT ID: NCT05557487
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6618 participants
OBSERVATIONAL
2022-12-15
2028-12-31
Brief Summary
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As described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field.
This is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan.
The primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects.
The primary objective of TRIO part B is the exact lung cancer detection rates in these three groups.
Other secondary objectives are also included.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Previous heavy smokers
Age 40 to 80 years who have at least a 20-pack-year smoking history with successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years
Low dose computed tomography
1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.
First degree relatives of lung cancer patients
First-degree relatives of lung cancer patients
1. aged more than 40 years
2. age less than 40 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family
Low dose computed tomography
1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.
With other high-risk occupational or environmental factors
Age 40 to 80 years, meet one or more of the following criteria.
1. air-pollution exposed occupations (such as traffic policeman, street cleaners….) for at least 10 years
2. cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking.
3. cooking without using ventilation for more than 20 years
4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with interval more than 5 years before this study
Low dose computed tomography
1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.
Interventions
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Low dose computed tomography
1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.
Eligibility Criteria
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Inclusion Criteria
1. Cigarette smoking of at least 20 pack-years
2. With successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years
Group 2: First-degree relatives of lung cancer patients
1. aged more than 50 years
2. age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family
Group 3: With other high-risk occupational or environmental factors Age 50 to 80 years, meet one or more of the following criteria.
1. air-pollution exposed occupations (such as traffic policemen, and street cleaners….) for at least 10 years
2. cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir-frying, or deep frying in one week \* years cooking.
3. cooking without using ventilation for more than 20 years
4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with intervals more than 5 years before this study
Exclusion Criteria
2. another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years
3. an inability to tolerate transthoracic procedures or thoracotomy
4. chest CT examination was performed within 18 months
5. hemoptysis of unknown etiology within one month
6. body weight loss of more than 6 kg within one year without an evident cause
7. a known pregnancy
8. Not capable of understanding or responding to the written questionnaire even through the help from the study team
20 Years
80 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Gee-Chen Chang
OTHER
Responsible Party
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Gee-Chen Chang
Chung Shan Medical University
Locations
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Chung Shan Medical University
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
Countries
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Central Contacts
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Facility Contacts
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Chong-Jen Yu, MD PhD
Role: primary
Chung-Ping Hsu, MD PhD
Role: primary
Yu-Feng Wei, MD PhD
Role: primary
Inn-Wen Chong, MD PhD
Role: primary
Po-Hao Feng, MD PhD
Role: primary
Chao-Chi Ho, MD PhD
Role: primary
References
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Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
National Lung Screening Trial Research Team; Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gierada DS, Jones GC, Mahon I, Marcus PM, Sicks JD, Jain A, Baum S. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120.
Patz EF Jr, Pinsky P, Gatsonis C, Sicks JD, Kramer BS, Tammemagi MC, Chiles C, Black WC, Aberle DR; NLST Overdiagnosis Manuscript Writing Team. Overdiagnosis in low-dose computed tomography screening for lung cancer. JAMA Intern Med. 2014 Feb 1;174(2):269-74. doi: 10.1001/jamainternmed.2013.12738.
US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.
Kim H, Kim HY, Goo JM, Kim Y. Lung Cancer CT Screening and Lung-RADS in a Tuberculosis-endemic Country: The Korean Lung Cancer Screening Project (K-LUCAS). Radiology. 2020 Jul;296(1):181-188. doi: 10.1148/radiol.2020192283. Epub 2020 Apr 14.
de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.
Other Identifiers
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CS1-22111
Identifier Type: -
Identifier Source: org_study_id
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