UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050121 |
|---|---|
| Receipt number | R000057099 |
| Scientific Title | Clinical evaluation study of Beta-glucan assay |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/24 20:04:46 |
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Basic information
Public title
Clinical evaluation study of Beta-glucan assay
Acronym
Evaluation study of an adjunctive diagnostic assay for invasive fungal infections
Scientific Title
Clinical evaluation study of Beta-glucan assay
Scientific Title:Acronym
Evaluation study of an adjunctive diagnostic assay for invasive fungal infections
Region
| Japan |
Condition
Condition
invasive fungal infections
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the clinical performance of each company's Beta-glucan assay reagents in various diseases of deep-seated mycosis. In addition, since there is a problem in the market that assay values differ among reagents, we aim to compare the assay values of each company and examine the compatibility between reagents of each company.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint: Diagnostic performance of Beta-glucan assay reagents
We will evaluate the application performance of each reagent by measuring specimens suspected of having deep-seated mycosis with each company's Beta-glucan assay reagent and comparing the results with the diagnostic results in a retrospective manner.
Key secondary outcomes
Secondary endpoint: Correlation of Beta-glucan assay reagents from various companies
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspected deep-seated mycosis and Beta-glucan measurement is performed
Key exclusion criteria
Patients whose consent cannot be obtained or who are deemed inappropriate by the physician in charge
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kakeya |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Infection Control Science
Zip code
545-8585
Address
1-4-3 Asahi--machi Abeno-ku Osaka
TEL
06-6645-3784
kakeya@omu.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Shibata |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Infection Control Science
Zip code
545-8585
Address
1-4-3 Asahi--machi Abeno-ku Osaka
TEL
06-6645-3784
Homepage URL
shibata.wataru@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Wako Pure Chemical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Medicine
Address
1-4-3 Asahi--machi Abeno-ku Osaka
Tel
06-6645-3784
kakeya@omu.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
| 2023 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Invasive fungal infections are on the rise as the number of immunocompromised patients increases. Currently, reagents for measuring Beta-D-glucan, which measure the outer wall components of fungi, are used to diagnose deep-seated mycosis and to determine the efficacy of antifungal drug therapy. The Beta-D-glucan measuring reagent is sold by two companies. The principle of measurement is the turbidimetric method, in which the presence of Beta-D-glucan causes turbidity in the reagent, and the colorimetric method, in which the presence of Beta-D-glucan causes a change in the color of the reagent and the concentration is measured by the rate of this change. There are also single-type reagents that use a single test tube for each test, and multi-type reagents that use a 96-well microplate. Each medical institution selects and uses reagents according to the purpose and situation of each facility. However, the differences in assay values among the kits of different companies have made it difficult to use the assay values from one kit to another. In this study, we will confirm the clinical performance of each company's assay reagents and compare the assay reagents of each company to examine the compatibility of assay values.
Management information
Registered date
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057099
