NCT07245407Fut, nem toboroz
A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE
A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 8.
Rövid összefoglaló (regiszter, angolul)
Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic respiratory disease characterized by a clinical syndrome of chronic productive cough and recurrent respiratory infections in the presence of abnormal and permanent dilation of the bronchi. Recent epidemiological studies have clearly shown that the prevalence and incidence of NCFBE are quickly rising both in high- and low-income countries. With the increase of prevalence, bronchiectasis brings huge medical and economic burden to the society. In this study, the investigator will perform biomarker assessments and multi-omics analysis on NCFBE patients and healthy participants in China to validate the link of disease pathways to pathophysiological features and uncover the molecular endotypes behind clinical phenotypesof Chinese patients with NCFBE.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 251 (tényleges)
- Első benyújtás
- 2025. szept. 29.
- Kezdés
- 2025. okt. 27.
- Elsődleges befejezés
- 2027. júl. 29.
- Fő szponzor
- AstraZeneca
- Betegségek
- Cisztás fibrózis
- NCT-szám
- NCT07245407
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 251
- 2025. okt. 27. és az elsődleges befejezés (2027. júl. 29.) között
- 38 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks or current sinusitis.
- Treatment with anti-coagulants.
- Bronchiectasis cohort:
Más betegség
- Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment).
- Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, any other connective tissue disease.
- Active malignancy excluding non-melanoma skin cancer.
- Traction bronchiectasis associated with interstitial lung disease or other pulmonary disorders (e.g., pulmonary fibrosis and cystic fibrosis).
- Primary diagnosis of another pulmonary condition, including COPD, asthma. Patients with a secondary diagnosis of these pulmonary diseases will be allowed to participate as long as bronchiectasis is considered by the investigator to be the primary diagnosis.
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
- The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
- Active malignancy excluding non-melanoma skin cancer.
- History or current evidence of an upper or lower respiratory infection or symptoms(including common cold) within 2 weeks of baseline assessments
- Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.
Egyéb
- Healthy control cohort:
- Any contraindication to study procedures including bronchoscopy.
- Current smoking or smoking in the preceding 3 months.
- Affect the safety of the participant throughout the study
- Influence the findings of the study or the interpretation
- Impede the participant's ability to complete the entire duration of study
- Participants is female who is pregnant or lactating or up to 6 weeks post-partum or 6 weeks cessation of breastfeeding.
- The participant has an altered mental status at the time of informed consent.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center).
Kiket keres a vizsgálat
- Healthy control cohort:
- Age ≥30 years
- Bronchiectasis cohort:
- Capable of giving signed informed consent.
- Participant must be ≥18 years of age, at the time of signing the ICF.
- Able to perform acceptable lung function testing according to ATS/ERS 2019 acceptability criteria.
- Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center, and use electronic devices (e.g. FENO and spirometry).
- Documented physician-diagnosed bronchiectasis: with a clinical history consistent with bronchiectasis (chronic cough and daily sputum production etc.) and having performed chest HRCT indicating bronchiectasis.
- Remaining clinically stable upon recruitment. Patients with exacerbations are allowed to be enrolled into the study at least 4 weeks after the end of exacerbations. If a patient experiencing exacerbation and directly enters the exacerbation visit, the patient is required to come to the study site for baseline visit (after confirming that all inclusion/exclusion criteria are met) within 4 weeks /+ 3 days after the end of exacerbation
Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (38)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Anning First People's Hospital | Anning | Kína | Ismeretlen állapot |
| Beijing Chaoyang Hospital affiliated to Capital Medical University | Beijing | Kína | Ismeretlen állapot |
| Peking University People's Hospital | Beijing | Kína | Ismeretlen állapot |
| Beijing Hospital | Beijing | Kína | Ismeretlen állapot |
| The Second Hospital of Jilin University | Changchun | Kína | Ismeretlen állapot |
| Xiangya Hospital of Central South University | Changsha | Kína | Ismeretlen állapot |
| West China Hospital of Sichuan University | Chengdu | Kína | Ismeretlen állapot |
| Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital | Chengdu | Kína | Ismeretlen állapot |
| Chengdu Fifth People's Hospital | Chengdu | Kína | Ismeretlen állapot |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Kína | Ismeretlen állapot |
| Guizhou Provincial People's Hospital | Guiyang | Kína | Ismeretlen állapot |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Kína | Ismeretlen állapot |
| Huzhou Central Hospital | Huzhou | Kína | Ismeretlen állapot |
| Jiaxing First Hospital | Jiaxing | Kína | Ismeretlen állapot |
| Jiaxing Second Hospital | Jiaxing | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Kína | Ismeretlen állapot |
| Gansu Provincial Hospital | Lanzhou | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of NanChang University | Nanchang | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Ningbo University | Ningbo | Kína | Ismeretlen állapot |
| Ningbo Fenghua District People's Hospital | Ningbo | Kína | Ismeretlen állapot |
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | Kína | Ismeretlen állapot |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Kína | Ismeretlen állapot |
| Shanghai Fifth People's Hospital | Shanghai | Kína | Ismeretlen állapot |
| Shanghai General Hospital | Shanghai | Kína | Ismeretlen állapot |
| Shanghai Pulmonary Hospital | Shanghai | Kína | Ismeretlen állapot |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Kína | Ismeretlen állapot |
| Huadong Hospital Affiliated to Fudan University | Shanghai | Kína | Ismeretlen állapot |
| Shanghai Tongji Hospital | Shanghai | Kína | Ismeretlen állapot |
| Shenzhen People's Hospital | Shenzhen | Kína | Ismeretlen állapot |
| Shiyan Taihe Hospital | Shiya | Kína | Ismeretlen állapot |
| Weifang People's Hospital | Weifang | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Kína | Ismeretlen állapot |
| The affiliated hospital of xuzhou medical university | Xuzhou | Kína | Ismeretlen állapot |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Kína | Ismeretlen állapot |
| Henan Provincial People's Hospital | Zhengzhou | Kína | Ismeretlen állapot |
| Zhengzhou People's Hospital | Zhengzhou | Kína | Ismeretlen állapot |
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