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Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response (CTOMICS)

2026年7月3日 更新者：Kim, Sang Hyuk、Korea University Guro Hospital

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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Clinical Research Office Korea University Guro Hospital
  • 电话号码：+82-2-2626-1659
  • 邮箱：kumc.guro.rst@kumc.or.kr

学习地点

  • 韩国
    • Dongjak-gu
      • Seoul、Dongjak-gu、韩国、07061
        • 招聘中
        • SMG-SNU Boramae Medical Center
        • 接触：
    • Guro-gu
      • Seoul、Guro-gu、韩国、08308
        • 招聘中
        • Korea University Guro Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adults aged 19 years or older with clinically diagnosed asthma or COPD who are receiving routine care at participating centers and consent to participate in a prospective observational cohort study involving clinical assessments, pulmonary function testing, and chest CT imaging.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
大体时间：From baseline to last follow-up visit (anticipated up to 12 months after enrollment)
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.
From baseline to last follow-up visit (anticipated up to 12 months after enrollment)

次要结果测量

结果测量
措施说明
大体时间
Change in Lung Function (FEV1)
大体时间：Baseline to 12 months
Change in pre-bronchodilator and/or post-bronchodilator FEV1 (mL) from baseline to last follow-up visit.
Baseline to 12 months
Frequency of acute exacerbations
大体时间：Up to 12 months after enrollment
Number of moderate or severe exacerbations during follow-up.
Up to 12 months after enrollment
Changes in Quantitative Chest CT Imaging Biomarkers (LAA-950, PRMfSAD, Pi10, BV5/TBV)
大体时间：Baseline to last follow-up visit (up to 12 months)
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.
Baseline to last follow-up visit (up to 12 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Korea University Guro Hospital

合作者

Seoul National University Boramae Hospital
The Korean Academy of Tuberculosis and Respiratory Diseases

调查人员

  • 首席研究员：Sang Hyuk Kim, MD、Korea University Guro Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月22日

初级完成 (估计的)

2027年11月30日

研究完成 (估计的)

2027年12月22日

研究注册日期

首次提交

2026年2月22日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CTOMICS1
  • 2025GR0637 (其他标识符：Korea University Guro Hospital IRB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data (IPD), including clinical variables, pulmonary function data, and quantitative chest CT metrics, may be shared with qualified investigators upon reasonable request. Data sharing will be subject to approval by the Institutional Review Board and execution of a data use agreement to ensure appropriate use, confidentiality, and protection of participant privacy. Requests may be submitted after publication of primary study results.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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