SNQ Quality Mark

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  • Animal Care & Products

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Target Population

  • Non-smoking high-risk lung cancer population (50-80)

  • Family history of lung cancer

  • Air pollution, secondhand smoke exposure

  • History of TB or COPD

  • Post-surgery early-stage (Stage I) lung cancer


Description

Led by Prof. Gee-Chen Chang, the Lung Cancer Diagnosis and Treatment Research Center at Chung Shan Medical University Hospital launched the FORMOSA Trial, a prospective multicenter study to develop a lung cancer risk prediction model for never-smokers. By integrating epidemiological data, air pollution exposure, biomarkers, and imaging characteristics, the study identifies high-risk individuals for precision screening to improve early detection and reduce lung cancer mortality. The model is being prospectively validated through collaboration with eight major medical centers across Taiwan. Our team was also the first in Taiwan to contribute lung cancer data to the National Health Data Alliance platform.

To date, the FORMOSA Trial has enrolled 2,439 participants and developed the FORMOSA Lung Cancer Risk Prediction Model for Taiwan’s never-smoking population, achieving a sensitivity of 90–96% and a negative predictive value of 98–99%.

The Center also participates in the Taiwan Cancer Moonshot Program and collaborates with the U.S. Cancer Moonshot initiative. Using over 14,000 proteogenomic datasets, the team developed a four-marker ELISA panel for early recurrence prediction, supporting personalized treatment and improved patient outcomes.


Key Highlights

  • Prospective enrollment of over 2,400 never-smokers in one of the world's most comprehensive lung cancer screening cohorts.

  • Taiwan's only prospective LDCT screening study integrating environmental exposures, multi-omics biomarkers, and AI radiomics.

  • Taiwan's first air pollution–integrated lung cancer risk prediction model for never-smokers.

  • LDCT detection rate of 2.54%, exceeding international benchmarks from NLST (0.65%) and NELSON (0.9%).

  • Taiwan's only prospective study on air pollution and lung cancer risk.

  • Novel ELISA-based blood test panel for early detection of lung cancer recurrence.

Service Data

  • FORMOSA enrollment: 2,436 (target 3,127)

  • LDCT detection rate: 2.5% (NLST 0.65%, NELSON 0.9%)

  • 2023 CSMUH lung cancer total cases: 871

  • Lung Cancer Moonshot: 14,000 proteogenomic entries

  • 89 patient plasma samples, 35 candidate proteins validated

  • 2024 TFDA LDTs certification achieved


Featured Outcomes

  • AI-assisted image interpretation improved diagnostic sensitivity by approximately 39.3%

  • Development of a precision screening strategy through a multidimensional risk-scoring system

  • Particularly high screening yield among never-smoking women, individuals aged ≥60 years, and those with high air pollution exposure

  • Overall lung cancer detection rate of 2.50% (61/2,439) in the prospective cohort


Safety Outcomes

  • LDCT radiation dose meets international standards

  • AI reduces missed diagnoses

  • High sensitivity avoids overtreatment

  • Multi-center IRB strict ethics review

  • High protein marker accuracy

  • International QA laboratory standards


Satisfaction

  • Provides early screening for high-risk groups

  • Reduces unnecessary surgery and treatment

  • Improves post-op recurrence monitoring

  • Enhances early diagnosis and survival

  • Transparent evidence-based pathway

  • Cross-institutional collaboration enhances service


International Achievements

  • Cell 2020 (IF 64.5): East Asian non-smoking proteogenomics

  • JTO 2023 (IF 20.1, Editor's Choice): Family-history LDCT

  • Lancet Respir Med 2024 (TALENT trial) lead author

  • 2023 IASLC cited our air pollution research

  • TW-US Cancer Moonshot 2.0 collaboration

  • Invited STC-D panelist


Benefits and Impacts

  • Provides evidence for national health policy

  • Drives AI imaging and precision medicine implementation

  • National Core Facility integrates 7 research units

  • Builds commercializable early recurrence prediction platform

  • Includes non-smokers in international lung cancer screening guidelines

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Specialized Medical Services

Risk-Prediction Screening for Early Lung Cancer

The FORMOSA Trial enables early detection and treatment of lung cancer in high-risk never-smokers, while a recurrence prediction assay supports personalized medicine to improve survival.
Organization
Chung Shan Medical University Hospital
Specialties/Units
Lung Cancer Diagnosis and Treatment Research Center
Certification Year
2024、2025
Risk-Prediction Screening for Early Lung Cancer
Chung Shan Medical University Hospital

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Pediatric Haploidentical Stem Cell Transplant
Chung Shan Medical University Hospital
>90
<5
Foolproof Drug Abuse Testing Network
Chung Shan Medical University Hospital
>5,000
>94
Transformational Leadership in Nursing
Chung Shan Medical University Hospital
96.79
8.2
Comprehensive Ischemic Stroke Care
Chung Shan Medical University Hospital
0
15.46
Health Data Analytics Support Platform
Chung Shan Medical University Hospital
31
15
Pharmaceutical Care with AI
Chung Shan Medical University Hospital
>86
<0.05
HIV;De-stigmatization & Education
Chung Shan Medical University Hospital
>92
>16,000
Comprehensive Pancreatic Care & Training
Chung Shan Medical University Hospital
24
452
Integrated Care for Young-Onset Dementia
Chung Shan Medical University Hospital
>526
>90
Seamlessly Hospice Sharing Comfort Care
Chung Shan Medical University Hospital
85
46.8
Pediatric Haploidentical Stem Cell Transplant
Chung Shan Medical University Hospital
>90
<5
Foolproof Drug Abuse Testing Network
Chung Shan Medical University Hospital
>5,000
>94