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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016760
Receipt No. R000019446
Scientific Title Clinical research evaluating efficiency of detection for pathogen of trichophytosis unguium by JNC-DD-001 as test paper to detect filamentous fungns in trichophytosis unguium diagnosis.
Date of disclosure of the study information 2015/03/10
Last modified on 2015/03/10

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Basic information
Public title Clinical research evaluating efficiency of detection for pathogen of trichophytosis unguium by JNC-DD-001 as test paper to detect filamentous fungns in trichophytosis unguium diagnosis.
Acronym Clinical research evaluating efficiency of detection for pathogen of trichophytosis unguium by JNC-DD-001
Scientific Title Clinical research evaluating efficiency of detection for pathogen of trichophytosis unguium by JNC-DD-001 as test paper to detect filamentous fungns in trichophytosis unguium diagnosis.
Scientific Title:Acronym Clinical research evaluating efficiency of detection for pathogen of trichophytosis unguium by JNC-DD-001
Region
Japan

Condition
Condition Suspition of trichophytosis unguium
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Compare efficiency of detection for pathogen of trichophytosis unguium to test samples from suspected area as trichophytosis unguium by JNC-DD-001 and by direct microscopy
Basic objectives2 Others
Basic objectives -Others Efficiency test of external diagnostic medicine
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of inconformity and positive, negative and total conformity of the diagnostics result from direct microscopy and JNC-DD-001 to detect pathogen of trichophytosis unguium from suspected area as trichophytosis unguium
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Extracorporeal diagnostic medicine
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 1) Patient suspected trichophytosis unguium
2) Patient must be at least 20 years of age. Then irrespective of sex
3) Does not matter inpatient or outpatient
4) Patient is fully informed about the study and has signed the informed consent form
Key exclusion criteria 1) Patient has used Oral antifungal drugs within 6 months or antifungal agent for external use within a month prior to enrolling in this study.
2) Patient on participating any clinical researches or trials
3) Patient recognized by principle investigator or sub investigator as inappropriate for this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seitarou Hiruma
Organization Ochanomizu Mycosis Allergy Laboratory
Division name -
Zip code
Address 2F Nakamura Bldg., 2-12-4, Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1089
Email mahiruma@cb3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Kusuhara
Organization EPS Associates Co.,Ltd
Division name Phamaceutical Dvelopment Project Division
Zip code
Address 2-1-3 Koraku, Bunkyo-ku, Tokyo 112-0004, Japan
TEL 03-3868-7303
Homepage URL
Email y.kusuhara.ro@eps-associates.com

Sponsor
Institute JNC Corporation
Institute
Department

Funding Source
Organization JNC 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
Address
Tel
Email

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
2015 Year 03 Month 10 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
2014 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 10 Day
Last modified on
2015 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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