- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07602192
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sang Hyuk Kim, MD
- 전화번호: +82-2-2626-1659
- 이메일: gost702@korea.ac.kr
연구 연락처 백업
- 이름: Clinical Research Office Korea University Guro Hospital
- 전화번호: +82-2-2626-1659
- 이메일: kumc.guro.rst@kumc.or.kr
연구 장소
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Guro-gu
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Seoul, Guro-gu, 대한민국, 08308
- 모병
- Korea University Guro Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Imaging and multi-omic signatures that differentiate asthma from COPD and predict treatment response
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Lung Function (FEV1)
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Sang Hyuk Kim, MD, Korea University Guro Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTOMICS1
- 2025GR0637 (기타 식별자: Korea University Guro Hospital IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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