Lung CancerTRIONCT05557487
Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration
An observational study of Lung Cancer and High-Risk Cancer, run by Gee-Chen Chang at 7 sites in Taiwan.
Trial summary
Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, High-Risk Cancer, Smoking
- What is being tested?
- Low dose computed tomography
- How many people
- 6,618 participants
- Where
- 7 sitesTaiwan
- Study dates
- 15 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: High risk population for lung cancer
Who may be able to join
- Group 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.
- Cigarette smoking of at least 20 pack-years
- 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
- aged more than 50 years
- age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family
Show all 11Show fewer
- Group 3: With other high-risk occupational or environmental factors Age 50 to 80 years, meet one or more of the following criteria.
- air-pollution exposed occupations (such as traffic policemen, and street cleaners….) for at least 10 years
- cooking index ≥ 110, defined as 2/7 * days cooking by pan frying, stir-frying, or deep frying in one week * years cooking.
- cooking without using ventilation for more than 20 years
- history of pulmonary tuberculosis and complete anti-tuberculosis treatment with intervals more than 5 years before this study
Who cannot join
- previous history of lung cancer
- another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years
- an inability to tolerate transthoracic procedures or thoracotomy
- chest CT examination was performed within 18 months
- hemoptysis of unknown etiology within one month
- body weight loss of more than 6 kg within one year without an evident cause
- a known pregnancy
- Not capable of understanding or responding to the written questionnaire even through the help from the study team
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
Chong-Jen Yu, MD PhD
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, 970473
Chung-Ping Hsu, MD PhD
- Not yet recruiting
E-Da Hospital
Kaohsiung City
Yu-Feng Wei, MD PhD
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Inn-Wen Chong, MD PhD
- Not yet recruiting
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City
Po-Hao Feng, MD PhD
- Recruiting
Chung Shan Medical University
Taichung, Taiwan, 402
GEECHEN CHANG, MD, PhD, +886-4-24739595 ext. 34414, geechen@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei
Chao-Chi Ho, MD PhD
About this study
Official title: Taiwan Real-world Low-dose Computed Tomography Screening behavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -Part B: LDCT Screening Outcome and Management
Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 * days cooking by pan frying, stir frying, or deep frying in one week * years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders.
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.
Read more
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.
- Conditions
- Lung Cancer, High-Risk Cancer, Smoking, Pollution; Exposure, Family Relations
- Being tested
- Low dose computed tomography
- Keywords
- Lung cancer, Low-dose computed tomography, Real world data, Lung cancer family history, Air pollution, Smoking, Lung cancer risk questionnaire
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose computed tomographyDiagnostic test
- 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.
- 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.
- 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.
- Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc.
- Check pulmonary function test.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Low dose computed tomography | |
| 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 Receives: Diagnostic Test: Low dose computed tomography | |
| 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 Receives: Diagnostic Test: Low dose computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants.
- Eligible participants must meet the inclusion and exclusion criteria of this study
- Only the one who completes the detailed questionnaire survey is counted.
Measured: 2 years
To investigate overall lung cancer detection rate of high lung cancer risk individuals
Cytological or Pathological proof of lung cancer to investigate the overall lung cancer detection rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start15 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gee-Chen Chang
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Gee-Chen Chang, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557487
- Sponsor's protocol ID
- CS1-22111
- Acronym
- TRIO
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25651787National 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.
PubMed 23697514Patz 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.
PubMed 24322569US 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.
PubMed 33687470Kim 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.
PubMed 32286195de 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.
PubMed 31995683
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Real-world Low-dose Computed Tomography Screening behavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -Part B: LDCT Screening Outcome and Management
- ClinicalTrials.gov ID
- NCT05557487
- Acronym / sponsor ID
- TRIO / CS1-22111
- Conditions
- Lung Cancer, High-Risk Cancer, Smoking, Pollution; Exposure, Family Relations
- Keywords
- Lung cancer, Low-dose computed tomography, Real world data, Lung cancer family history, Air pollution, Smoking, Lung cancer risk questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,618 participants (estimated)
- Lead sponsor
- Gee-Chen ChangUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 * days cooking by pan frying, stir frying, or deep frying in one week * years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previous heavy smokers | – | Diagnostic Test: Low dose computed tomographyAge 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 |
| First degree relatives of lung cancer patients | – | Diagnostic Test: Low dose computed tomographyFirst-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 |
| With other high-risk occupational or environmental factors | – | Diagnostic Test: Low dose computed tomographyAge 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- High risk population for lung cancer
Key inclusion criteria (11 listed)
- Group 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.
- Cigarette smoking of at least 20 pack-years
- 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
- aged more than 50 years
Key exclusion criteria (8 listed)
- previous history of lung cancer
- another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years
- an inability to tolerate transthoracic procedures or thoracotomy
- chest CT examination was performed within 18 months
- hemoptysis of unknown etiology within one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose computed tomography1. 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. | Diagnostic test | First degree relatives of lung cancer patients, Previous heavy smokers, With other high-risk occupational or environmental factors |
Primary outcome
The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants.
Time frame: 2 years
1. Eligible participants must meet the inclusion and exclusion criteria of this study 2. Only the one who completes the detailed questionnaire survey is counted.
To investigate overall lung cancer detection rate of high lung cancer risk individuals
Time frame: 2 years
Cytological or Pathological proof of lung cancer to investigate the overall lung cancer detection rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 25651787Torre 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.
- Background: PubMed 23697514National 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.
- Background: PubMed 24322569Patz 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.
- Background: PubMed 33687470US 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.
- Background: PubMed 32286195Kim 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.
- Background: PubMed 31995683de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and High-Risk Cancer, run by Gee-Chen Chang at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GeeChen Chang, MD. PhD (+886-4-24739595 ext. 34414, geechen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557487, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.