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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| First degree relatives of lung cancer patients | First-degree relatives of lung cancer patients
|
| |
| With other high-risk occupational or environmental factors | Age 40 to 80 years, meet one or more of the following criteria.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose computed tomography | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants. |
| 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 | 2 years |
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Inclusion Criteria:
Group 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.
Group 2: First-degree relatives of lung cancer patients
Group 3: With other high-risk occupational or environmental factors Age 50 to 80 years, meet one or more of the following criteria.
Exclusion Criteria:
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High risk population for lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GeeChen Chang, MD. PhD | Contact | +886-4-24739595 | 34414 | geechen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Recruiting | Taichung | Taiwan | 402 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25651787 | Background | 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. | |
| 23697514 | Background | 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. |
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blood samples, urine samples, lung tissue samples.
|
| National Taiwan University Hospital Hsin-Chu Branch | Recruiting | Hsinchu | Taiwan |
|
| Hualien Tzu Chi Hospital | Recruiting | Hualien City | 970473 | Taiwan |
|
| E-Da Hospital | Not yet recruiting | Kaohsiung City | Taiwan |
|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| Ministry of Health and Welfare Shuang-Ho Hospital | Not yet recruiting | New Taipei City | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| 24322569 | Background | 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. |
| 33687470 | Background | 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. |
| 32286195 | Background | 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. |
| 31995683 | Background | 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. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
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