Clinical trial NCT03643653: The Establishment of China Bronchiectasis Registry and Research Collaboration
Official title: The Establishment of China Bronchiectasis Registry and the Optimal Treatment Research Collaboration for Bronchiectasis (BEChina)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis
Keywords: Bronchiectasis
multi-centered registry
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Zhongshan Hospital
First posted: 2018-08-23
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with all-cause bronchiectasis would be included, such as those with tuberculosis history and genetic disorders.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bronchiectasis according to 'non-cystic fibrosis bronchiectasis guideline' published by British Thoracic Society in 2010.
* Patients who are willing to sign the consent form and participate in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of patients enrolled in the registry
timeFrame: 3 years
Secondary outcomes:
measure: Lung Function (FEV1, FVC, FEV1% pred, FVC% pred etc.)
timeFrame: recorded at baseline and re-tested every year, up to 3 years.
measure: Exacerbation
timeFrame: up to 3 years
measure: Aetiology
timeFrame: at baseline
measure: Microbiology
timeFrame: At least 1 year before enrollment and 3 years during the follow-up
measure: Comorbidity
timeFrame: At baseline and updated every year for up to 3 years
measure: Quality of Life Questionnaire-Bronchiectasis
timeFrame: At baseline and updated once a year for 3 years
measure: Bronchiectasis severity Score (BSI)
timeFrame: At baseline and updated once a year for 3 years
measure: E-FACED score
timeFrame: At baseline and updated once a year for 3 years
measure: Mortality
timeFrame: 3 years
measure: modified Medical Research Council (mMRC) dyspnea score
timeFrame: At baseline and updated once a year for 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital , Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-Fu Xu, MD
role: STUDY_CHAIR
References:
citation: Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.