UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015625 |
|---|---|
| Receipt number | R000018157 |
| Scientific Title | Screening test of Fabry disease by pain in children |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2014/11/07 14:11:58 |
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Basic information
Public title
Screening test of Fabry disease by pain in children
Acronym
Screening test in Fabry disease
Scientific Title
Screening test of Fabry disease by pain in children
Scientific Title:Acronym
Screening test in Fabry disease
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish an easy diagnostic method on Fabry disease utilizing the enzyme assay in children with pain.
Basic objectives2
Others
Basic objectives -Others
To establish an easy diagnostic method on Fabry disease utilizing the enzyme assay in children with pain, we study the levels of plasma galactosidase A and globotriaosylsphingosine.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To detect the patients with Fabry disease in their early stages.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
If the levels of plasma Lyso-Gb3 was higher than the normal levels.
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients developed pain
Key exclusion criteria
Not to be able to obtain the informed coscent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Yamamoto |
Organization
St. Marianna University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-16-1 Sugao, Miyamae, Kawasaki
TEL
044-977-8111
h3yama@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Yamamoto |
Organization
St. Marianna University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-16-1 Sugao, Miyamae, Kawasaki
TEL
044-977-8111
Homepage URL
h3yama@marianna-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2014 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018157
