UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039838 |
|---|---|
| Receipt number | R000045424 |
| Scientific Title | Diagnostic utility of Aspergillus IgG, IgA, and IgM for chronic pulmonary aspergillosis: systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/03/17 |
| Last modified on | 2021/02/18 16:36:18 |
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Basic information
Public title
Diagnostic utility of Aspergillus IgG, IgA, and IgM for chronic pulmonary aspergillosis: systematic review and meta-analysis
Acronym
Diagnostic utility of Aspergillus IgG, IgA, and IgM for chronic pulmonary aspergillosis: systematic review and meta-analysis
Scientific Title
Diagnostic utility of Aspergillus IgG, IgA, and IgM for chronic pulmonary aspergillosis: systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic utility of Aspergillus IgG, IgA, and IgM for chronic pulmonary aspergillosis: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
chronic pulmonary aspergillosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of usefulness of Aspergillus IgG, IgA, and IgM for diagnosis of chronic pulmonary aspergillosis
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and spedificity
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pre-existing chronic pulmonary disease (cavitation, nodule/mass, pleural thickening, fibrosis, etc.) including regions caused by Aspergillus.
Key exclusion criteria
1) Comorbid advanced cancer
2) Using prednisolone-equivalent systemic steroid treatment of more than 10 mg/day for >3 weeks
3) Using immunosuppressive drugs or biologics (e.g. TNF inhibitor, IL-6 inhibitor, anti-CD20 monoclonal antibody, methotrexate, etc.) within the past 90 days.
4) inherited severe immunodeficiency
5) acquired immunodeficiency syndrome (AIDS)
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Anan |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
ekusiek_7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Anan |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
Homepage URL
ekusiek_7@yahoo.co.jp
Sponsor or person
Institute
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4646
ekusiek_7@yahoo.co.jp
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
| 2020 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/myc.13253
Number of participants that the trial has enrolled
0
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
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 06 | Month | 20 | Day |
Other
Other related information
<Search method>
MEDLINE, etc.
<Assessing the risk of bias>
Assess the risk of bias of the included studies using the revised Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool modified for this study.
<Meta-analysis>
Integrate the results of the primary studies using a hierarchical model.
<Subgroup analysis>
Evaluate the heterogeneity by visual assessment using SROC plot and forest plot. Perform the following subgroup analysis to assess heterogeneity.
1. Age; younger than 65 years old, 65 years old or older
2. Types of chronic pulmonary aspergillosis; aspergilloma, other than aspergilloma
3. Aspergillus species; Aspergillus fumigatus, Non-fumigatus Aspergillus species
4. Method of measurement of aspergillus antibodies; Aspergillus precipitating antibody, EIA method, ELISA method, Immunochromatography method, etc.
Compare the differences in the assay method for Aspergillus antibodies by relative diagnostic odds ratio.
<Sensitivity analysis>
Perform the following sensitivity analysis on primary outcomes.
1. Exclusion from the meta-analysis studies at high risk of bias in domain 1 of QUADAS-2 tool
2) Exclusion from the meta-analysis studies in which the ideal reference standard was not adopted
<Summary of findings table>
Create the SOF tables about the following outcomes based on the recommendation of Cochrane Handbook.
Patients/population, Prior testing, Settings, Index test, Reference standard, Study designs, Prevalence, No. of participants (studies), Sensitivity (Fixed at 90%), Specificity (Under a fixed sensitivity of 90%), Number of false positives out of 100,000 patients, Number of false negatives out of 100,000 patients, Quality and comments.
<ethical approval>
NA
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045424
