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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015625
Receipt No. 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

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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
Email 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
Email h3yama@marianna-u.ac.jp

Sponsor
Institute Department of Pediatrics
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018157

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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