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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name