UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056075 |
|---|---|
| Receipt number | R000064042 |
| Scientific Title | B-D-Glucan in Intraocular Fluids for Fungal Endophthalmitis: A Meta-Analysis of Diagnostic Test Accuracy |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 15:38:37 |
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Basic information
Public title
Meta-Analysis on the Usefulness of B-D-Glucan Testing in Intraocular Fluids for the Diagnosis of Fungal Endophthalmitis
Acronym
Meta-Analysis of B-D-Glucan for Fungal Endophthalmitis Diagnosis
Scientific Title
B-D-Glucan in Intraocular Fluids for Fungal Endophthalmitis: A Meta-Analysis of Diagnostic Test Accuracy
Scientific Title:Acronym
Meta-Analysis of B-D-Glucan for Fungal Endophthalmitis Diagnosis
Region
| Japan |
Condition
Condition
Fungal Endophthalmitis
Classification by specialty
| Infectious disease | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fungal endophthalmitis (FE) is a severe intraocular inflammatory disease caused by fungal infection. Early treatment is crucial, as delayed diagnosis can lead to rapid disease progression, risking structural eye damage and permanent vision loss. B-D-Glucan (BDG), found in the cell walls of many fungi, serves as a diagnostic marker for systemic fungal infections and may aid in the early diagnosis of FE when measured in aqueous humor and vitreous fluid. However, the diagnostic sensitivity and specificity of BDG in intraocular fluids remain unclear. This study conducts a meta-analysis of existing literature to assess BDG's diagnostic value for FE, aiming to contribute to more timely and accurate diagnostic methods.
Basic objectives2
Others
Basic objectives -Others
This study conducts a meta-analysis aimed at evaluating the diagnostic accuracy (sensitivity and specificity) of measuring B-D-glucan (BDG) levels in intraocular fluids for the diagnosis of fungal endophthalmitis. By integrating diagnostic accuracy, this research seeks to contribute to the establishment of an early and accurate diagnostic method for FE, providing evidence for treatment improvements to prevent vision loss.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, area under the curve (AUC), and diagnostic odds ratio (DOR) will be evaluated. If a study includes a range of cut-offs, the data point closest to the widely used cut-off of 20 pg/mL for serum BDG on a log scale will be selected for analysis.
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
| 10 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Included studies will be case-control, cross-sectional, prospective, or retrospective clinical studies that provide sufficient data on both the sensitivity and specificity of BDG for FE. Original studies must provide sufficient data to calculate at least one of AUC-ROC, DOR, or combined sensitivity and specificity of BDG for diagnosing fungal endophthalmitis. The reference standard is a clinical diagnosis by a physician, and the specimens included in the study will be aqueous humor and vitreous fluid. Sensitivity is defined as the number of true positives divided by the sum of true positives and false negatives, while specificity is defined as the number of true negatives divided by the sum of true negatives and false positives. No age restrictions will be imposed, nor will there be restrictions on publication date. No language restrictions will apply if sufficient data is provided. Both full-length articles and brief reports will be included.
Key exclusion criteria
Studies reporting only sensitivity or specificity will be excluded, as this precludes conducting a bivariate meta-analysis. Duplication of data will be avoided and duplicate use will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 JAPAN Department of Ophthalmology Yokohama City University School of Medicine
TEL
81-45-787-2683
mizuki.yuk.xj@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 JAPAN
TEL
81-45-787-2683
Homepage URL
mizuki.yuk.xj@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University School of Medicine Department of Ophthalmology and Visual Science
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 JAPAN
Tel
81-45-787-2683
mizuki.yuk.xj@yokohama-cu.ac.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
| 2024 | Year | 11 | Month | 06 | 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
I will proceed with my research at this time.
Results date posted
| 2024 | Year | 11 | Month | 04 | Day |
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two researchers conduct an independent assessment of the seven domains of the Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). A bivariate model is employed to calculate the overall estimates of sensitivity and specificity, and a summary ROC curve (SROC) is constructed from this pooled data. Pooled DOR will be calculated using the DerSimonian-Laird method, a random effects model, with the madauni command in the netmeta package of R (developed by Gerta Rucker from Denmark), while the reitsma command within the same package will be employed to pool sensitivity, specificity, and AUC. For interpreting AUC, values will be classified as excellent for >=0.97, very good for 0.93-0.96, good for 0.75-0.92, and fair for 0.5-0.74. The level of statistical significance is set at 0.05.
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064042
