UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038799 |
|---|---|
| Receipt number | R000044234 |
| Scientific Title | Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2020/06/05 10:52:00 |
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Basic information
Public title
Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Acronym
Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Scientific Title
Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic accuracy and safety of inhalation challenge tests for bird fancier's lung: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
bird fancier's lung
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This systematic review aimed to assess the diagnostic accuracy of inhalation challenge tests and adverse reactions after the tests.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity of inhalation challenge tests
Key secondary outcomes
Complication after inhalation challenge tests
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Randomized control trials, prospective or retrospective cohort studies, or case-control studies assessing either the sensitivity and specificity of inhalation challenge tests among patients who were suspected of BFL, 2. Randomized control trials, prospective or retrospective cohort studies, case-control studies, case series, or case reports describing adverse reactions of inhalation challenge tests.
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Shiroshita |
Organization
Kameda Medical Center
Division name
Department of pulmonology
Zip code
2968602
Address
929, Higashi-cho, Kamogawa city, Chiba
TEL
0470922211
akihirokun8@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | Shiroshita |
| Last name | Shiroshita |
Organization
Kameda Medical Center
Division name
Department of pulmonology
Zip code
2968602
Address
929, Higashi-cho, Kamogawa city, Chiba
TEL
0470922211
Homepage URL
akihirokun8@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929, Higashi-cho, Kamogawa city, Chiba
Tel
0470922211
akihirokun8@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We searched for articles evaluating diagnostic accuracy of inhalation challenge tests or articles describing adverse reaction, in Medline, Embase, the Cochrane Library, the International Clinical Trials Registry Platform, and the Web of Science. We described a hierarchical summary receiver operating characteristic (HSROC) curve to evaluate sensitivity and specificity of the challenge tests. We summarized subjective adverse reactions and use of steroid treatment for adverse reactions described in the articles.
Management information
Registered date
| 2019 | Year | 12 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044234
