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临床试验/NCT03643653
NCT03643653招募中不适用

The Establishment of China Bronchiectasis Registry and the Optimal Treatment Research Collaboration for Bronchiectasis (BEChina)

Shanghai Pulmonary Hospital, Shanghai, China2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
2
主要终点
Number of patients enrolled in the registry

研究概览

简要总结

The investigators meant to establish a multi-centered bronchiectasis patient registry for Chinese bronchiectasis patients. This would be the first bronchiectasis registry in China. Patients with all kinds of bronchiectasis would be enrolled.

详细描述

A multi-centered bronchiectasis patient registry would be founded, which will include patients from three teaching hospital (Ruijin Hospital, Zhongshan Hospital and Shanghai Pulmonary Hospital) in Shanghai at the beginning. The network will be promoted to other cities and different places in China. Patients with bronchiectasis would be enrolled and detailed information would be recorded. Follow-up of patients would provide more information on the prognosis of disease. Optimal treatment studies for the patients will be initiated one by one based on the network. The investigators are committed to promoting clinical research and education in bronchiectasis, through sharing of protocols, research idea and expertise.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with bronchiectasis according to 'non-cystic fibrosis bronchiectasis guideline' published by British Thoracic Society in
  • Patients who are willing to sign the consent form and participate in the study.

排除标准

  • Patients with incomplete essential information, which is needed for the integrity of data analysis. Essential information include CT images, respiratory sample cultures, spirometry and exacerbation history for at least one year.
  • Patients under 18 years old.

结局指标

主要结局

Number of patients enrolled in the registry

时间窗: 3 years

To establish a multi-centered bronchiectasis registry in Shanghai

次要结局

  • Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.)(recorded at baseline and re-tested every year, up to 3 years.)
  • Microbiology(At least 1 year before enrollment and 3 years during the follow-up)
  • Mortality(3 years)
  • Bronchiectasis severity Score (BSI)(At baseline and updated once a year for 3 years)
  • modified Medical Research Council (mMRC) dyspnea score(At baseline and updated once a year for 3 years)
  • Aetiology(at baseline)
  • Exacerbation(up to 3 years)
  • Quality of Life Questionnaire-Bronchiectasis(At baseline and updated once a year for 3 years)
  • E-FACED score(At baseline and updated once a year for 3 years)
  • Comorbidity(At baseline and updated every year for up to 3 years)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Fu Xu

Chief of Respiratory and Critical Care Medicine

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (2)

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