UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016760 |
|---|---|
| Receipt number | 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 11:13:51 |
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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
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
y.kusuhara.ro@eps-associates.com
Sponsor or person
Institute
JNC Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019446
