Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response (CTOMICS)
Prospective Multicenter Cohort to Discriminate Asthma Versus Chronic Obstructive Pulmonary Disease and Predict Treatment Response Using Quantitative Chest CT and Multi-Omics
This study aims to improve the diagnosis and treatment prediction of asthma and chronic obstructive pulmonary disease (COPD) by combining quantitative chest computed tomography (CT) imaging with multi-omics data.
Adults with asthma or COPD will be enrolled and undergo routine clinical evaluations, pulmonary function tests, blood tests, and chest CT scans. Additional samples, such as sputum and microbiome specimens, may also be collected. No experimental drugs or devices will be administered as part of this study.
Researchers will analyze CT imaging features together with clinical, laboratory, and biological data to better distinguish asthma from COPD and to identify factors that may predict treatment response. The findings are expected to contribute to more precise and personalized management of chronic airway diseases.
Visão geral do estudo
Status
Descrição detalhada
This is a prospective, observational, multi-center cohort study designed to integrate quantitative chest CT imaging with multi-omics data to improve differentiation between asthma and chronic obstructive pulmonary disease (COPD) and to identify biomarkers associated with treatment response.
Eligible participants will include adults diagnosed with asthma or COPD who agree to participate in longitudinal clinical follow-up. At baseline and during follow-up, participants will undergo standard clinical assessments, including symptom questionnaires, pulmonary function testing, blood sampling, and chest CT imaging. Additional biological samples, such as sputum and microbiome specimens, may be collected when clinically feasible.
Quantitative CT metrics (e.g., low attenuation area percentage, parametric response mapping features, airway wall measurements, and mucus plug scores) will be extracted from imaging data. These imaging biomarkers will be integrated with clinical variables, laboratory parameters (including inflammatory markers and immunoglobulin profiles), and microbiome data.
The primary objectives are: (1) to identify imaging and biological signatures that distinguish asthma from COPD, and (2) to determine whether these signatures can predict response to standard clinical treatments. No investigational drugs or medical devices are involved, and all procedures reflect routine clinical care.
Data will be analyzed using advanced statistical and computational methods to explore associations between imaging, biological markers, and clinical outcomes. Results are expected to enhance understanding of disease mechanisms and support the development of personalized treatment strategies for chronic airway diseases.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Sang Hyuk Kim, MD
- Número de telefone: +82-2-2626-1659
- E-mail: gost702@korea.ac.kr
Estude backup de contato
- Nome: Clinical Research Office Korea University Guro Hospital
- Número de telefone: +82-2-2626-1659
- E-mail: kumc.guro.rst@kumc.or.kr
Locais de estudo
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Guro-gu
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Seoul, Guro-gu, Coréia do Sul, 08308
- Recrutamento
- Korea University Guro Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age ≥19 years
- COPD group: post-bronchodilator FEV1/FVC < 0.70
- Asthma group: clinically confirmed diagnosis of asthma by a physician
- Able to provide voluntary written informed consent
Exclusion Criteria:
- Acute exacerbation or active lower respiratory tract infection (e.g., pneumonia) within the past 4 weeks
- Pregnancy or breastfeeding
- Inability to undergo chest CT (e.g., poor cooperation or severe medical condition)
- Refusal to consent to study procedures
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Prospective Asthma-COPD Cohort
This cohort includes adults with physician-diagnosed asthma or chronic obstructive pulmonary disease (COPD) who are enrolled in a prospective, observational study.
Participants undergo routine clinical assessments, pulmonary function testing, blood sampling, and chest computed tomography (CT) imaging as part of standard care and study-related data collection.
No investigational drugs or medical devices are administered.
Data from clinical evaluations, imaging, and biospecimens (e.g., blood and sputum) will be analyzed to characterize disease features and predict treatment response.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
Prazo: From baseline to last follow-up visit (anticipated up to 12 months after enrollment)
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Composite signatures derived from quantitative chest CT metrics (e.g., low attenuation area percentage, parametric response mapping features, airway measurements, and mucus plug score) integrated with clinical variables, pulmonary function indices, blood-based inflammatory markers, and sputum/microbiome profiles.
These integrated features will be evaluated for their ability to (1) distinguish asthma from COPD and (2) predict clinical treatment response.
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From baseline to last follow-up visit (anticipated up to 12 months after enrollment)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Lung Function (FEV1)
Prazo: Baseline to 12 months
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Change in pre-bronchodilator and/or post-bronchodilator FEV1 (mL) from baseline to last follow-up visit.
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Baseline to 12 months
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Frequency of acute exacerbations
Prazo: Up to 12 months after enrollment
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Number of moderate or severe exacerbations during follow-up.
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Up to 12 months after enrollment
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Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)
Prazo: Baseline to last follow-up visit (up to 12 months)
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Changes in chest CT-derived quantitative imaging biomarkers including parametric response mapping of functional low attenuation area at -950 HU (LAA-950), small airway disease (PRMfSAD), airway wall thickness (Pi10), and small vessel fraction (BV5/TBV) from baseline to last follow-up visit.
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Baseline to last follow-up visit (up to 12 months)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sang Hyuk Kim, MD, Korea University Guro Hospital
Publicações e links úteis
Publicações Gerais
- Chaudhary MFA, Bhatt SP. Imaging Endpoints for Biologic Therapy in Chronic Obstructive Pulmonary Disease. Br J Radiol. 2025 Jul 31:tqaf179. doi: 10.1093/bjr/tqaf179. Online ahead of print.
- Trivedi A, Hall C, Hoffman EA, Woods JC, Gierada DS, Castro M. Using imaging as a biomarker for asthma. J Allergy Clin Immunol. 2017 Jan;139(1):1-10. doi: 10.1016/j.jaci.2016.11.009.
- Bhatt SP, Han MK. Developing and Implementing Biomarkers and Novel Imaging in COPD. Chronic Obstr Pulm Dis. 2016 Jan 15;3(1):485-490. doi: 10.15326/jcopdf.3.1.2015.0170.
- Kim SH, Yang Z, Chang SW, Sim JK, Oh JY, Min KH, Hur GY, Lee SY, Shim JJ, Choi J, Yong HS. Airway Quantification Using Ultra-Low-Dose Computed Tomography Correlates With Pulmonary Function Indices in Patients With Asthma. J Korean Med Sci. 2026 Feb 2;41(5):e56. doi: 10.3346/jkms.2026.41.e56.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Doenças do sistema imunológico
- Doenças Respiratórias
- Doenças pulmonares
- Doenças brônquicas
- Doenças Pulmonares Obstrutivas
- Hipersensibilidade Respiratória
- Hipersensibilidade, Imediata
- Hipersensibilidade
- Condições Patológicas, Sinais e Sintomas
- Doença Pulmonar Obstrutiva Crônica
- Asma
- Doença
Outros números de identificação do estudo
- CTOMICS1
- 2025GR0637 (Outro identificador: Korea University Guro Hospital IRB)
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