Lung CancerNCT02611570
LDCT Screening in Non-smokers in Taiwan
An observational study of Lung Cancer, run by Academia Sinica, Taiwan at 17 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LDCT
- How many people
- 12,000 participants
- Where
- 17 sitesTaiwan
- Study dates
- Oct 2014to Jul 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: High risk population for lung cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Taiwan17 sites
Chiayi Chang Gung Memorial Hospital
Chiayi City, 61363
Hualien Tzu Chi Hospital
Hualien City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
E-Da Cancer Hospital
Kaohsiung City
Shuang-Ho Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung, 40201
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei, 112
Taipei Veterans General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 114
Taipei Medical University Hospital
Taipei
Wan Fang Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan City, 33001
About this study
Official title: Low Dose Computed Tomography Screening Study in Non-smokers with Risk Factors for Lung Cancer in Taiwan
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.
Read the 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. In this study, we plan to enroll 12000 non-smoker subjects with a given lung cancer risk; half of them should have lung cancer family history. Each participant will receive LDCT at baseline, annually for two years, and biennially for 6 years. Our overall goal is to establish a risk assessment model of lung cancer in non-smokers and provide suggestions to government for considerations for lung cancer prevention and screening policy in Taiwan.
There are three specific aims in our proposed study:
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.
- Conditions
- Lung Cancer
- Being tested
- LDCT
- Keywords
- Lung cancer, Low dose computed tomography, Screening, Non-smoker, Gender issue
- Medical subject headings
- Lung Neoplasms, Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDCTOther
LDCT at enrollment, annually for two years and biennially for 6 years if no lung cancer is detected
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: LDCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
Monitoring the occurrence of lung cancer
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
Measured: 5 years
Monitoring the recurrence of lung cancer
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)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
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Lung Cancer Society, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), 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, Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Pan-Chyr Yang, MD, PhD, Academia Sinica, Taiwan
- Investigators
- Pan-Chyr Yang, M.D., Ph.D., Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611570
- Sponsor's protocol ID
- AS-IRB-BM-15039
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2015
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
PubMed 24399786International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476.
PubMed 17065637Field JK, Oudkerk M, Pedersen JH, Duffy SW. Prospects for population screening and diagnosis of lung cancer. Lancet. 2013 Aug 24;382(9893):732-41. doi: 10.1016/S0140-6736(13)61614-1.
PubMed 23972816Melamed MR, Flehinger BJ, Zaman MB, Heelan RT, Perchick WA, Martini N. Screening for early lung cancer. Results of the Memorial Sloan-Kettering study in New York. Chest. 1984 Jul;86(1):44-53. doi: 10.1378/chest.86.1.44.
PubMed 6734291Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD; PLCO Project Team. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011 Nov 2;306(17):1865-73. doi: 10.1001/jama.2011.1591. Epub 2011 Oct 26.
PubMed 22031728Sobue T, Moriyama N, Kaneko M, Kusumoto M, Kobayashi T, Tsuchiya R, Kakinuma R, Ohmatsu H, Nagai K, Nishiyama H, Matsui E, Eguchi K. Screening for lung cancer with low-dose helical computed tomography: anti-lung cancer association project. J Clin Oncol. 2002 Feb 15;20(4):911-20. doi: 10.1200/JCO.2002.20.4.911.
PubMed 11844811Henschke CI. Early lung cancer action project: overall design and findings from baseline screening. Cancer. 2000 Dec 1;89(11 Suppl):2474-82. doi: 10.1002/1097-0142(20001201)89:11+3.3.co;2-u.
PubMed 11147630Gohagan J, Marcus P, Fagerstrom R, Pinsky P, Kramer B, Prorok P; Writing Committee, Lung Screening Study Research Group. Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute. Chest. 2004 Jul;126(1):114-21. doi: 10.1378/chest.126.1.114.
PubMed 15249451National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641Diederich S, Wormanns D. Impact of low-dose CT on lung cancer screening. Lung Cancer. 2004 Aug;45 Suppl 2:S13-9. doi: 10.1016/j.lungcan.2004.07.997.
PubMed 15552777Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
PubMed 23315954Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.
PubMed 22710039Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
PubMed 22610500Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
PubMed 24378917Croswell JM, Baker SG, Marcus PM, Clapp JD, Kramer BS. Cumulative incidence of false-positive test results in lung cancer screening: a randomized trial. Ann Intern Med. 2010 Apr 20;152(8):505-12, W176-80. doi: 10.7326/0003-4819-152-8-201004200-00007.
PubMed 20404381
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Computed Tomography Screening Study in Non-smokers with Risk Factors for Lung Cancer in Taiwan
- ClinicalTrials.gov ID
- NCT02611570
- Acronym / sponsor ID
- AS-IRB-BM-15039
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Low dose computed tomography, Screening, Non-smoker, Gender issue
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- Taiwan Lung Cancer Society, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), 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, Ministry of Health and Welfare, Taiwan
- Study start
- Oct 2014
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Nov 2015 (estimated)
- 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.
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.
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. In this study, we plan to enroll 12000 non-smoker subjects with a given lung cancer risk; half of them should have lung cancer family history. Each participant will receive LDCT at baseline, annually for two years, and biennially for 6 years. Our overall goal is to establish a risk assessment model of lung cancer in non-smokers and provide suggestions to government for considerations for lung cancer prevention and screening policy in Taiwan.
There are three specific aims in our proposed study:
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-smokers at risk for lung cancer | – | Other: LDCT1. Non-smoking subjects with lung cancer family history 2. Non-smoking subjects with a given lung cancer risk other than lung cancer family history |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- High risk population for lung cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| LDCTLDCT at enrollment, annually for two years and biennially for 6 years if no lung cancer is detected | Other | Non-smokers at risk for lung cancer |
Primary outcome
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.
2 secondary outcomes
Monitoring the occurrence of lung cancer
Time frame: 5 years
Monitoring the recurrence of lung cancer
Time frame: 5 years
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 30 Oct 2024.
- Background: PubMed 24399786Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
- Background: PubMed 17065637International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476.
- Background: PubMed 23972816Field JK, Oudkerk M, Pedersen JH, Duffy SW. Prospects for population screening and diagnosis of lung cancer. Lancet. 2013 Aug 24;382(9893):732-41. doi: 10.1016/S0140-6736(13)61614-1.
- Background: PubMed 6734291Melamed MR, Flehinger BJ, Zaman MB, Heelan RT, Perchick WA, Martini N. Screening for early lung cancer. Results of the Memorial Sloan-Kettering study in New York. Chest. 1984 Jul;86(1):44-53. doi: 10.1378/chest.86.1.44.
- Background: PubMed 22031728Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD; PLCO Project Team. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011 Nov 2;306(17):1865-73. doi: 10.1001/jama.2011.1591. Epub 2011 Oct 26.
- Background: PubMed 11844811Sobue T, Moriyama N, Kaneko M, Kusumoto M, Kobayashi T, Tsuchiya R, Kakinuma R, Ohmatsu H, Nagai K, Nishiyama H, Matsui E, Eguchi K. Screening for lung cancer with low-dose helical computed tomography: anti-lung cancer association project. J Clin Oncol. 2002 Feb 15;20(4):911-20. doi: 10.1200/JCO.2002.20.4.911.
- Background: PubMed 11147630Henschke CI. Early lung cancer action project: overall design and findings from baseline screening. Cancer. 2000 Dec 1;89(11 Suppl):2474-82. doi: 10.1002/1097-0142(20001201)89:11+3.3.co;2-u.
- Background: PubMed 15249451Gohagan J, Marcus P, Fagerstrom R, Pinsky P, Kramer B, Prorok P; Writing Committee, Lung Screening Study Research Group. Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute. Chest. 2004 Jul;126(1):114-21. doi: 10.1378/chest.126.1.114.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 15552777Diederich S, Wormanns D. Impact of low-dose CT on lung cancer screening. Lung Cancer. 2004 Aug;45 Suppl 2:S13-9. doi: 10.1016/j.lungcan.2004.07.997.
- Background: PubMed 23315954Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
- Background: PubMed 22710039Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.
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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. This study is not recruiting at the moment.
Pan-Chyr Yang, M.D., Ph.D. principal investigator
National Taiwan University
17 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, run by Academia Sinica, Taiwan at 17 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of LDCT for lung cancer among non-smokers (time frame: 3 years). 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 NCT02611570, which also lists 65 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 30 Oct 2024.