UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038613 |
|---|---|
| Receipt number | R000044008 |
| Scientific Title | Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium. |
| Date of disclosure of the study information | 2019/11/18 |
| Last modified on | 2020/09/28 10:05:06 |
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Basic information
Public title
Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium.
Acronym
Clinical research evaluating efficiency of trichophyton antigen kit in tinea unguium.
Scientific Title
Clinical research evaluating efficiency of detection for antigen of tinea by trichophyton antigen kit in tinea unguium.
Scientific Title:Acronym
Clinical research evaluating efficiency of trichophyton antigen kit in tinea unguium.
Region
| Japan |
Condition
Condition
Tinea Unguium
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficiency of detection for antigen of tinea by trichophyton antigen kit in Tinea unguium.
Basic objectives2
Others
Basic objectives -Others
Performance evaluation of a diagnostic test
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance and discordance rates between the detection results of antigen of tinea by trichophyton antigen kit and the diagnosis of tinea unguium by KOH direct microscopy.
Key secondary outcomes
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 enrolled in the study must meet the following 1)2)3)and 5)or 1)2)4)and 5).
1)Patients aged at least 20 years at the time of enrolment.
2)Patients who have understood the purpose of the study and provided written informed consent for participation in this study.
3)Patients who diagnosed as tinea unguium by KOH direct microscopy. The disease types are all types(DLSO,SWO,PSO,TDO). Specifically, positive is defined as the presence of fungal elements discovered by KOH direct microscopy at a magnification of 100 times. "Weakly positive(+)" is the case that single dermatophyte is discovered in multiple field, and "strongly positive(++)"is the case that multiple dermatophyte are discovered in multiple field.
4)Patients who diagnosed as non tines unguium by KOH direct microscopy for other diseases in the nail area(for example malformed nail).
5)Patients who has residual samples which is collected at the time of KOH direct microscopy at usual clinical care.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study.
1)Patients who has received oral antifungal drugs within 6 months(180 days) or patient who has received antifungal agent for external use within a month(30 days) prior to the enrolment.
2)Patients who participates in other clinical studies(except for observational study).
3)Patients determined to be inappropriate to be enrolled in this study by investigators.
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Sawada |
Organization
Maruho Co., Ltd.
Division name
Diagnostics Department
Zip code
531-0071
Address
11th floor, Nakatsu Center Building, 1-11-1, Nakatsu, Kita-ku, Osaka, 531-0071, Japan
TEL
06-6371-8005
sawada_apg@mii.maruho.co.jp
Public contact
Name of contact person
| 1st name | Fuminobu |
| Middle name | |
| Last name | Tomonari |
Organization
Linical Co., Ltd.
Division name
Contract Medical Affairs Unit, Clinical Trail Operations
Zip code
105-0021
Address
18th floor, Shiodome Sumitomo Building, 1-9-2, Higashi-shimbashi, Minato-ku, Tokyo, 105-0021, Japan
TEL
03-6215-8005
Homepage URL
tomonari-fuminobu@linical.co.jp
Sponsor or person
Institute
Maruho Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
JNC CORPORATION
Linical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
飯田橋皮膚科スキンクリニック（東京都）
医療法人社団 いとう皮ふ科（東京都）
神奈川はた皮膚科クリニック（神奈川県）
すずき皮膚科（東京都）
仲皮フ科クリニック（埼玉県）
はまぐち皮フ科（東京都）
まるやま皮膚科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
To evaluate efficiency of detection for antigen of tinea by trichophyton antigen kit in Tinea unguium.
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044008
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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