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AzTrials

Lung Cancer (Diagnosis)NCT07383454

Lung Cancer Screening in Population Who Had Never Smoked

A study testing Low dose computed tomography in people with Lung Cancer (Diagnosis) and Non-Small Cell Lung Cancer, run by Chung Shan Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Study design: prospective, single arm. Objectives: survey lung cancer detection rate of low-dose computed tomography (LDCT) screening in individuals who had never smoked. Participants will undergo questionnaires, and collecting specimens including blood, urine, and medical informations including results of pulmonary… Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
What is being tested?
Low dose computed tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
No sites listed yet
Study dates
1 Feb 2026to Dec 2034
Phase
Interventional
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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals with no history of smoking.
  • Aged 40 to 80 years.
  • Willing to provide written informed consent and complete questionnaire assessments.
  • After undergoing examinations, willing to provide relevant biological information, including but not limited to: blood samples, urine samples, pulmonary function test results, imaging data, and tissue specimens obtained from invasive biopsies or surgical procedures (if applicable).

Who cannot join

  • History of lung cancer, or a diagnosis of any malignancy other than skin cancer or cervical carcinoma in situ within the past five years.
  • Undergoing chest computed tomography (CT) scans within the past 18 months.
  • Unexplained hemoptysis within the past one month.
  • Unexplained weight loss exceeding 6 kilograms within the past one year.
  • Pregnancy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gee-Chen Chang, MD, PhD. contact

886-4-24739595 ext. 34414

geechen@gmail.com

Lung-Ying Huang, Mrs. contact

886-4-24739595 ext. 34414

cshe1365@csh.org.tw

About this study

Official title: Lung Cancer Screening in Population Who Had Never Smoked and the Validation of Lung Cancer Risk Prediction Model

Study design: prospective, single arm.

Objectives: survey lung cancer detection rate of low-dose computed tomography (LDCT) screening in individuals who had never smoked.

Participants will undergo questionnaires, and collecting specimens including blood, urine, and medical informations including results of pulmonary function tests, and LDCT screening upon inclusion. The participants will be followed up according to current standards of clinical practice.

Read the detailed description

Lung cancer remains the leading cause of cancer-related mortality worldwide, with a particularly high incidence and mortality rate in Taiwan. Notably, over half of lung cancer cases in Taiwan occur among individuals who have never smoked, a pattern distinct from Western populations. In response to this unique epidemiological profile, this project aims to promote community-based lung cancer screening among never-smokers and to validate the FORMOSA lung cancer risk prediction model, which integrates demographic, environmental, genetic, and clinical factors.

This prospective, single-arm, open-label study will recruit approximately 2,500 participants aged 40 to 80 years with no history of smoking, through hospital and community outreach. Eligible participants will provide informed consent and undergo comprehensive assessments, including questionnaires on lifestyle and environmental exposures, low-dose computed tomography (LDCT), chest X-ray, pulmonary function tests, and collection of blood and urine samples. LDCT results will be interpreted according to the modified ACR Lung-RADS v1.1 criteria. Biological specimens will be used for biomarker, heavy metal, genetic, and proteomic analyses. Participants with abnormal findings will be followed according to standard clinical protocols, and tissue samples from invasive procedures will be retained for further molecular studies.

The primary outcomes include the lung cancer detection rate among never-smoked participants and the validation metrics (sensitivity, specificity, positive and negative predictive values) of the FORMOSA lung cancer risk prediction model. Statistical analyses will employ descriptive statistics, Kaplan-Meier survival analysis, log-rank tests, Cox proportional hazards models, and group comparisons using ANOVA, Kruskal-Wallis, chi-square, Fisher's exact tests, and logistic-regression. Preliminary data suggest that the FORMOSA model can identify high-risk individuals with a lung cancer detection rate of 2.8-3.3%, significantly higher than the general population rate of 0.78%.

This project is expected to enhance early detection of lung cancer in never-smokers, improve public awareness, and establish a robust epidemiological database for Taiwan. The validation of the FORMOSA model will provide a scientific basis for refining screening strategies and inform future public health policies targeting high-risk, non-smoking populations. The study is conducted with strict adherence to ethical standards, ensuring participant rights and data security. Funding is provided by the Ministry of Health and Welfare's "Healthy Taiwan Deep Cultivation Plan." In summary, this research addresses a critical gap in lung cancer prevention by focusing on never-smokers, leveraging a comprehensive risk prediction model, and implementing a community-based screening approach. The anticipated outcomes will contribute significantly to reducing late-stage lung cancer diagnoses and mortality, and serve as a reference for future health policy development in Taiwan and similar populations.

Being tested
Low dose computed tomography
Keywords
Low dose computed tomography (LDCT), Lung cancer in individuals who had never smoked (LCINS), Lung cancer risk prediction model (LCRPM), Lung cancer, Non-small cell lung cancer (NSCLC)
Medical subject headings
Lung Neoplasms, Disease, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose computed tomographyDiagnostic test

    Low dose computed tomography for lung cancer screening

Study groups in NCT07383454
Study groupRoleWhat they receive
LDCT screening armExperimentalLDCT screening, lung function test, and specimens collections
Receives: Diagnostic Test: Low dose computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung cancer detection rate

    The rate of lung cancer diagnosis during follow up periord.

    Measured: 8 years of follow-up

Secondary outcomes (1)

  1. AUROC of FORMOSA Lung Cancer Risk Prediction Model

    Assess the sensitivity, specificity, positive predicting value, negative predicting value, and ROC analysis of FORMOSA Lung Cancer Risk Prediction Model

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07383454
Sponsor's protocol ID
CS1-26008
Status last verified
Jan 2026
First submitted
26 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi J, Shiraishi K, Choi J, Matsuo K, Chen TY, Dai J, Hung RJ, Chen K, Shu XO, Kim YT, Landi MT, Lin D, Zheng W, Yin Z, Zhou B, Song B, Wang J, Seow WJ, Song L, Chang IS, Hu W, Chien LH, Cai Q, Hong YC, Kim HN, Wu YL, Wong MP, Richardson BD, Funderburk KM, Li S, Zhang T, Breeze C, Wang Z, Blechter B, Bassig BA, Kim JH, Albanes D, Wong JYY, Shin MH, Chung LP, Yang Y, An SJ, Zheng H, Yatabe Y, Zhang XC, Kim YC, Caporaso NE, Chang J, Ho JCM, Kubo M, Daigo Y, Song M, Momozawa Y, Kamatani Y, Kobayashi M, Okubo K, Honda T, Hosgood DH, Kunitoh H, Patel H, Watanabe SI, Miyagi Y, Nakayama H, Matsumoto S, Horinouchi H, Tsuboi M, Hamamoto R, Goto K, Ohe Y, Takahashi A, Goto A, Minamiya Y, Hara M, Nishida Y, Takeuchi K, Wakai K, Matsuda K, Murakami Y, Shimizu K, Suzuki H, Saito M, Ohtaki Y, Tanaka K, Wu T, Wei F, Dai H, Machiela MJ, Su J, Kim YH, Oh IJ, Lee VHF, Chang GC, Tsai YH, Chen KY, Huang MS, Su WC, Chen YM, Seow A, Park JY, Kweon SS, Chen KC, Gao YT, Qian B, Wu C, Lu D, Liu J, Schwartz AG, Houlston R, Spitz MR, Gorlov IP, Wu X, Yang P, Lam S, Tardon A, Chen C, Bojesen SE, Johansson M, Risch A, Bickeboller H, Ji BT, Wichmann HE, Christiani DC, Rennert G, Arnold S, Brennan P, McKay J, Field JK, Shete SS, Le Marchand L, Liu G, Andrew A, Kiemeney LA, Zienolddiny-Narui S, Grankvist K, Johansson M, Cox A, Taylor F, Yuan JM, Lazarus P, Schabath MB, Aldrich MC, Jeon HS, Jiang SS, Sung JS, Chen CH, Hsiao CF, Jung YJ, Guo H, Hu Z, Burdett L, Yeager M, Hutchinson A, Hicks B, Liu J, Zhu B, Berndt SI, Wu W, Wang J, Li Y, Choi JE, Park KH, Sung SW, Liu L, Kang CH, Wang WC, Xu J, Guan P, Tan W, Yu CJ, Yang G, Sihoe ADL, Chen Y, Choi YY, Kim JS, Yoon HI, Park IK, Xu P, He Q, Wang CL, Hung HH, Vermeulen RCH, Cheng I, Wu J, Lim WY, Tsai FY, Chan JKC, Li J, Chen H, Lin HC, Jin L, Liu J, Sawada N, Yamaji T, Wyatt K, Li SA, Ma H, Zhu M, Wang Z, Cheng S, Li X, Ren Y, Chao A, Iwasaki M, Zhu J, Jiang G, Fei K, Wu G, Chen CY, Chen CJ, Yang PC, Yu J, Stevens VL, Fraumeni JF Jr, Chatterjee N, Gorlova OY, Hsiung CA, Amos CI, Shen H, Chanock SJ, Rothman N, Kohno T, Lan Q. Genome-wide association study of lung adenocarcinoma in East Asia and comparison with a European population. Nat Commun. 2023 May 26;14(1):3043. doi: 10.1038/s41467-023-38196-z.

    PubMed 37236969

  • Diaz-Gay M, Zhang T, Hoang PH, Leduc C, Baine MK, Travis WD, Sholl LM, Joubert P, Khandekar A, Zhao W, Steele CD, Otlu B, Nandi SP, Vangara R, Bergstrom EN, Kazachkova M, Pich O, Swanton C, Hsiung CA, Chang IS, Wong MP, Leung KC, Sang J, McElderry JP, Hartman C, Colon-Matos FJ, Miraftab M, Saha M, Lee OW, Jones KM, Gallego-Garcia P, Yang Y, Zhong X, Edell ES, Santamaria JM, Schabath MB, Yendamuri SS, Manczuk M, Lissowska J, Swiatkowska B, Mukeria A, Shangina O, Zaridze D, Holcatova I, Mates D, Milosavljevic S, Kontic M, Bosse Y, Rothberg BEG, Christiani DC, Gaborieau V, Brennan P, Liu G, Hofman P, Yang L, Nowak MA, Shi J, Rothman N, Wedge DC, Homer R, Yang SR, Pesatori AC, Consonni D, Lan Q, Zhu B, Chanock SJ, Choi J, Alexandrov LB, Landi MT. The mutagenic forces shaping the genomes of lung cancer in never smokers. Nature. 2025 Aug;644(8075):133-144. doi: 10.1038/s41586-025-09219-0. Epub 2025 Jul 2.

    PubMed 40604281

  • Chen IC, Chen YM, Yang HW, Tseng JS, Yang TY. Interplay of Polygenic Risk Score, Smoking Statuses, and Air Pollution on Lung Adenocarcinoma Risk in a Taiwanese Population. Respirology. 2025 Apr;30(4):317-325. doi: 10.1111/resp.70004. Epub 2025 Feb 16.

    PubMed 39956994

  • Blechter B, Chien LH, Chen TY, Chang IS, Choudhury PP, Hsiao CF, Shu XO, Wong JYY, Chen KY, Chang GC, Tsai YH, Su WC, Huang MS, Chen YM, Chen CY, Hung HH, Hu JW, Shi J, Zheng W, Rositch AF, Chen CJ, Chatterjee N, Yang PC, Rothman N, Hsiung CA, Lan Q. Polygenic Risk Score, Environmental Tobacco Smoke, and Risk of Lung Adenocarcinoma in Never-Smoking Women in Taiwan. JAMA Netw Open. 2023 Nov 1;6(11):e2339254. doi: 10.1001/jamanetworkopen.2023.39254.

    PubMed 37955902

  • Blechter B, Wong JYY, Agnes Hsiung C, Hosgood HD, Yin Z, Shu XO, Zhang H, Shi J, Song L, Song M, Zheng W, Wang Z, Caporaso N, Burdette L, Yeager M, Berndt SI, Teresa Landi M, Chen CJ, Chang GC, Hsiao CF, Tsai YH, Chen KY, Huang MS, Su WC, Chen YM, Chien LH, Chen CH, Yang TY, Wang CL, Hung JY, Lin CC, Perng RP, Chen CY, Chen KC, Li YJ, Yu CJ, Chen YS, Chen YH, Tsai FY, Jie Seow W, Bassig BA, Hu W, Ji BT, Wu W, Guan P, He Q, Gao YT, Cai Q, Chow WH, Xiang YB, Lin D, Wu C, Wu YL, Shin MH, Hong YC, Matsuo K, Chen K, Pik Wong M, Lu D, Jin L, Wang JC, Seow A, Wu T, Shen H, Fraumeni JF, Yang PC, Chang IS, Zhou B, Chanock SJ, Rothman N, Chatterjee N, Lan Q. Sub-multiplicative interaction between polygenic risk score and household coal use in relation to lung adenocarcinoma among never-smoking women in Asia. Environ Int. 2021 Feb;147:105975. doi: 10.1016/j.envint.2020.105975. Epub 2020 Dec 29.

    PubMed 33385923

  • Coradduzza D, Congiargiu A, Azara E, Mammani IMA, De Miglio MR, Zinellu A, Carru C, Medici S. Heavy metals in biological samples of cancer patients: a systematic literature review. Biometals. 2024 Aug;37(4):803-817. doi: 10.1007/s10534-024-00583-4. Epub 2024 Feb 12.

    PubMed 38347295

  • Lee NW, Wang HY, Du CL, Yuan TH, Chen CY, Yu CJ, Chan CC. Air-polluted environmental heavy metal exposure increase lung cancer incidence and mortality: A population-based longitudinal cohort study. Sci Total Environ. 2022 Mar 1;810:152186. doi: 10.1016/j.scitotenv.2021.152186. Epub 2021 Dec 6.

    PubMed 34883183

  • Huang HH, Huang JY, Lung CC, Wu CL, Ho CC, Sun YH, Ko PC, Su SY, Chen SC, Liaw YP. Cell-type specificity of lung cancer associated with low-dose soil heavy metal contamination in Taiwan: an ecological study. BMC Public Health. 2013 Apr 10;13:330. doi: 10.1186/1471-2458-13-330.

    PubMed 23575356

  • Yoon HY, Kim SY, Song JW. Association between high levels of nitrogen dioxide and increased cumulative incidence of lung cancer in patients with idiopathic pulmonary fibrosis. Eur Respir J. 2024 May 30;63(5):2301181. doi: 10.1183/13993003.01181-2023. Print 2024 May.

    PubMed 38453259

  • Hamra GB, Laden F, Cohen AJ, Raaschou-Nielsen O, Brauer M, Loomis D. Lung Cancer and Exposure to Nitrogen Dioxide and Traffic: A Systematic Review and Meta-Analysis. Environ Health Perspect. 2015 Nov;123(11):1107-12. doi: 10.1289/ehp.1408882. Epub 2015 Apr 14.

    PubMed 25870974

  • Lin WC, Shie RH, Yuan TH, Tseng CH, Chiang CJ, Lee WC, Chan CC. A nationwide case-referent study on elevated risks of adenocarcinoma lung cancer by long-term PM2.5 exposure in Taiwan since 1997. Environ Res. 2024 Jul 1;252(Pt 2):118889. doi: 10.1016/j.envres.2024.118889. Epub 2024 Apr 8.

    PubMed 38599452

  • Jones RR, Fisher JA, Hasheminassab S, Kaufman JD, Freedman ND, Ward MH, Sioutas C, Vermeulen R, Hoek G, Silverman DT. Outdoor Ultrafine Particulate Matter and Risk of Lung Cancer in Southern California. Am J Respir Crit Care Med. 2024 Feb 1;209(3):307-315. doi: 10.1164/rccm.202305-0902OC.

    PubMed 37856832

  • Hill W, Lim EL, Weeden CE, Lee C, Augustine M, Chen K, Kuan FC, Marongiu F, Evans EJ Jr, Moore DA, Rodrigues FS, Pich O, Bakker B, Cha H, Myers R, van Maldegem F, Boumelha J, Veeriah S, Rowan A, Naceur-Lombardelli C, Karasaki T, Sivakumar M, De S, Caswell DR, Nagano A, Black JRM, Martinez-Ruiz C, Ryu MH, Huff RD, Li S, Fave MJ, Magness A, Suarez-Bonnet A, Priestnall SL, Luchtenborg M, Lavelle K, Pethick J, Hardy S, McRonald FE, Lin MH, Troccoli CI, Ghosh M, Miller YE, Merrick DT, Keith RL, Al Bakir M, Bailey C, Hill MS, Saal LH, Chen Y, George AM, Abbosh C, Kanu N, Lee SH, McGranahan N, Berg CD, Sasieni P, Houlston R, Turnbull C, Lam S, Awadalla P, Gronroos E, Downward J, Jacks T, Carlsten C, Malanchi I, Hackshaw A, Litchfield K; TRACERx Consortium; DeGregori J, Jamal-Hanjani M, Swanton C. Lung adenocarcinoma promotion by air pollutants. Nature. 2023 Apr;616(7955):159-167. doi: 10.1038/s41586-023-05874-3. Epub 2023 Apr 5.

    PubMed 37020004

  • Loomis D, Huang W, Chen G. The International Agency for Research on Cancer (IARC) evaluation of the carcinogenicity of outdoor air pollution: focus on China. Chin J Cancer. 2014 Apr;33(4):189-96. doi: 10.5732/cjc.014.10028.

    PubMed 24694836

  • Loomis D, Grosse Y, Lauby-Secretan B, El Ghissassi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Baan R, Mattock H, Straif K; International Agency for Research on Cancer Monograph Working Group IARC. The carcinogenicity of outdoor air pollution. Lancet Oncol. 2013 Dec;14(13):1262-3. doi: 10.1016/s1470-2045(13)70487-x. No abstract available.

    PubMed 25035875

Questions about this trial

What is this clinical trial studying?

A study testing Low dose computed tomography in people with Lung Cancer (Diagnosis) and Non-Small Cell Lung Cancer, run by Chung Shan Medical University.

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 5 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Gee-Chen 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?

Lung cancer detection rate (time frame: 8 years of follow-up). 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 NCT07383454, which also lists 22 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 3 Feb 2026.

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