UMIN-CTR Clinical Trial

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
Email	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
Email	ekusiek_7@yahoo.co.jp

Sponsor
Institute	Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045424