UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062358 |
|---|---|
| Receipt number | R000071039 |
| Scientific Title | The Utility of the IgM ELISA Assay and the Indirect IgA Fluorescence Assay |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/07/28 08:11:20 |
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Basic information
Public title
A study of serological testing methods for cat-scratch disease-related eye disorders: uveitis(optic neuritis and retinitis), Parinaud's syndrome
Acronym
A Study of Serological Testing Methods for Cat-Scratch Disease
Scientific Title
The Utility of the IgM ELISA Assay and the Indirect IgA Fluorescence Assay
Scientific Title:Acronym
The Utility of the IgM ELISA Assay and the Indirect IgA Fluorescence Assay
Region
| Japan |
Condition
Condition
Eye Diseases Associated with Scratch Fever (Uveitis [Optic Neuritis and Retinitis], Parinaud's Ocular Gland Syndrome)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of conventional methods, B. henselae IgM antibodies (IFA) and IgG antibodies (IFA) in cases suspected of cat-scratch disease-related ocular disorders.
To investigate whether adding new serological tests, B. henselae IgM antibodies (ELISA) and B. henselae IgA antibodies (IFA), improves diagnostic accuracy.
To compare the clinical presentation, ocular findings, treatment course, and visual prognosis between antibody-positive and antibody-negative groups, thereby clarifying the clinical characteristics of cat-scratch disease-related eye disorders.
To collect basic data that will contribute to understanding the current status of cat-scratch disease-related eye disorders in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints will be diagnostic accuracy, sensitivity, specificity, likelihood ratio, and area under the ROC curve for cat-scratch disease-related eye disorders, as assessed using each of the following test methods: B. henselae IgM antibodies (IFA), IgG antibodies (IFA), IgM antibodies (ELISA), and IgA antibodies (IFA)-as well as various combinations thereof.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Additional Blood Sampling for Research Purposes
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
| 2 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients presenting with ocular findings consistent with cat-scratch disease uveitis or Parinaud's syndrome. Ocular findings of cat-scratch disease uveitis include optic neuritis, optic disc edema, radial white spots, multiple choroidal infiltrates, serous retinal detachment, vitreous opacities, serous retinal detachment or intraretinal fluid accumulation on OCT, and retinal vasculitis on fluorescein angiography. Ocular findings of Parinaud's syndrome include unilateral conjunctival injection, mucopurulent discharge, granulomatous follicular conjunctivitis, and ipsilateral lymphadenitis.
Patients with a history of contact with cats, dogs, or other animals, or patients for whom the attending physician suspects contact with animals.
Patients aged 2 years or older but under 80 years at the time of obtaining informed consent.
Gender and status, outpatient or inpatient, are not restricted. Patients who have received a thorough explanation regarding participation in this study, and for whom written informed consent has been obtained from the patient or a legal representative.
Key exclusion criteria
Patients for whom the period between the onset of ocular findings and the start of the study exceeds 8 weeks.
Patients whom the principal investigator or a co-investigator determines to have significant difficulty understanding the study due to dementia or other conditions, and who are unable to make an appropriate decision regarding participation in this study in a manner that best represents their own interests.
Patients for whom blood collection is deemed medically inappropriate.
Any other patients whom the principal investigator or a co-investigator determines to be unsuitable as study participants.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Yanai |
Organization
Tokushima University Graduate School
Division name
Department of Ophthalmology, Institute of Biomedical Sciences,
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima
TEL
0886317163
yanai@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Yanai |
Organization
Tokushima University Graduate School
Division name
Department of Ophthalmology, Institute of Biomedical Sciences,
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima
TEL
0886317163
Homepage URL
yanai@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Ryoji Yanai
Funding Source
Organization
Tokushima University Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of Tokushima University
Address
3-18-15 Kuramoto, Tokushima
Tel
0886317163
first-ec@tokushima-u.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
| 2026 | Year | 09 | Month | 30 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071039
