- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555865
Aetiology of Children With Bronchiectasis in China
January 6, 2017 updated by: Baoping XU, Beijing Children's Hospital
Aetiology of Children With Bronchiectasis in China--A Multicenter Retrospective Study
This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.
Study Overview
Status
Unknown
Conditions
Detailed Description
This study is divided into two parts.
Part I. Retrospective review the 10 years medical records of the children with bronchiectasis from every center, and investigate the etiology of the cases by the standard diagnostic process.
Part II.
All new cases of bronchiectasis which was confirmed diagnosed at every center from the beginning of the study are made the investigation of the etiology by the standard diagnostic process.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100045
- Recruiting
- Beijing Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
Description
Inclusion Criteria:A included patient must be coincident at least one point of the four items of HRCT manifestations.
- Internal bronchial diameter greater than the accompanying pulmonary artery.
- lack of bronchial tapering
- bronchi visible in the peripheral 1cm of lung
- bronchial diameter greater than adjacent segmental bronchi
Exclusion Criteria:Subject will be excluded if she or he has one of the following
- It is unable to provide complete medical records or the current condition can not accept the diagnosis process
- It does not agree to participate in the test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with differential causes of bronchiectasis by reviewing the medical records or undergoing the standard diagnostic process
Time Frame: 48 months
|
The cause of each paticipant with bronchiectasis will be recorded, for example post infection, PCD, PID, et al.
|
48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
- Amorim A, Gracia Roldan J. Bronchiectasis: do we need aetiological investigation? Rev Port Pneumol. 2011 Jan-Feb;17(1):32-40. English, Portuguese.
- Gaillard EA, Carty H, Heaf D, Smyth RL. Reversible bronchial dilatation in children: comparison of serial high-resolution computer tomography scans of the lungs. Eur J Radiol. 2003 Sep;47(3):215-20. doi: 10.1016/s0720-048x(02)00122-5.
- Eastham KM, Fall AJ, Mitchell L, Spencer DA. The need to redefine non-cystic fibrosis bronchiectasis in childhood. Thorax. 2004 Apr;59(4):324-7. doi: 10.1136/thx.2003.011577.
- Brower KS, Del Vecchio MT, Aronoff SC. The etiologies of non-CF bronchiectasis in childhood: a systematic review of 989 subjects. BMC Pediatr. 2014 Dec 10;14:4. doi: 10.1186/s12887-014-0299-y.
- LIU Xiu-yun, JIANG Zai-fang. The etiology of ninety-one children with bronchiecatsis. J Clin Pediatr, 2011, 29(2):127-129.
- CHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.
- WANG Hao,XU Bao-ping,LIU Xiu-yun,HU Ying-hui,REN Yi-xin,SHEN Kun-ling. Clinical characteristics and follow-up of bronchiectasis in children. Chinese Journal of Practical Pediatrics, 2014;29 (12):936-939.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (ANTICIPATED)
March 1, 2022
Study Completion (ANTICIPATED)
March 1, 2022
Study Registration Dates
First Submitted
September 14, 2015
First Submitted That Met QC Criteria
September 20, 2015
First Posted (ESTIMATE)
September 22, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 9, 2017
Last Update Submitted That Met QC Criteria
January 6, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCHlung002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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