BronchiectasisNCT02555865
Aetiology of Children With Bronchiectasis in China
An observational study of Bronchiectasis, run by Beijing Children's Hospital at 1 site in China.
Trial summary
This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children'S Hospital
Beijing, Beijing Municipality, 100045
baoping xu
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiectasis
- Keywords
- etiology, children
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with differential causes of bronchiectasis by reviewing the medical records or undergoing the standard diagnostic process
The cause of each paticipant with bronchiectasis will be recorded, for example post infection, PCD, PID, et al.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJun 2016
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan women and children's health care center, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Changchun Children's Hospital, Shenzhen Children's Hospital, Jiangxi Province Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Tianjin Children's Hospital, The First Affiliated Hospital of Xiamen University, The Affiliated Hospital Of Guizhou Medical University, Shanxi Provincial Maternity and Children's Hospital
- Responsible party
- Principal investigator, Baoping XU, Beijing Children's Hospital
- Investigators
- Kunling Shen, MD,PhD, Study director, Beijing Children's Hospital of Capital Medical University, ChinaBaoping Xu, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, ChinaXiaoxia Peng, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555865
- Sponsor's protocol ID
- BCHlung002
- Status last verified
- Jan 2017
- First submitted
- 14 Sep 2015
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
PubMed 11986413Amorim A, Gracia Roldan J. Bronchiectasis: do we need aetiological investigation? Rev Port Pneumol. 2011 Jan-Feb;17(1):32-40. English, Portuguese.
PubMed 21251482Gaillard 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.
PubMed 12927665Eastham 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.
PubMed 15047953Brower 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.
PubMed 25492164LIU 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 at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiology of Children With Bronchiectasis in China--A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT02555865
- Acronym / sponsor ID
- BCHlung002
- Conditions
- Bronchiectasis
- Keywords
- etiology, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Wuhan women and children's health care center, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Changchun Children's Hospital, Shenzhen Children's Hospital, Jiangxi Province Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Tianjin Children's Hospital, The First Affiliated Hospital of Xiamen University, The Affiliated Hospital Of Guizhou Medical University, Shanxi Provincial Maternity and Children's Hospital
- Study start
- Jun 2016
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who was confirmed diagnosis as bronchiectasis at the certain hospitals (sponsor and collaborators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 11986413Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.
- Background: PubMed 21251482Amorim A, Gracia Roldan J. Bronchiectasis: do we need aetiological investigation? Rev Port Pneumol. 2011 Jan-Feb;17(1):32-40. English, Portuguese.
- Background: PubMed 12927665Gaillard 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.
- Background: PubMed 15047953Eastham 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.
- Background: PubMed 25492164Brower 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.
- BackgroundLIU Xiu-yun, JIANG Zai-fang. The etiology of ninety-one children with bronchiecatsis. J Clin Pediatr, 2011, 29(2):127-129.
- BackgroundCHEN Jun, DUO Li-kun, WANG Xiao-feng. Clinical analysis of 22 children with bronchiectasis. J Clin Pediatr, 2012, 30(1):51-54.
- BackgroundWANG 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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunling Shen, MD,PhD study director
Beijing Children's Hospital of Capital Medical University, China
Baoping Xu, MD,PhD principal investigator
Beijing Children's Hospital of Capital Medical University, China
Xiaoxia Peng, MD,PhD principal investigator
Beijing Children's Hospital of Capital Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baoping Xu, MD,PhD (861059616308, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with differential causes of bronchiectasis by reviewing the medical records or undergoing the standard diagnostic process (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555865, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.