UMIN-ICDS Clinical Trial

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

invasive fungal infections

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kakeya@omu.ac.jp

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

Email

shibata.wataru@omu.ac.jp

Institute

Osaka Metropolitan University

Institute

Department

Personal name

Organization

FUJIFILM Wako Pure Chemical Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Metropolitan University Graduate School of Medicine

Address

1-4-3 Asahi--machi Abeno-ku Osaka

Tel

06-6645-3784

Email

kakeya@omu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000057099