UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019954 |
|---|---|
| Receipt number | R000023042 |
| Scientific Title | Gastrointestinal involvement in Fabry disease by biopsy using endoscope |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2021/06/25 16:30:44 |
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Basic information
Public title
Gastrointestinal involvement in Fabry disease by biopsy using endoscope
Acronym
Gastrointestinal involvement in Fabry disease
Scientific Title
Gastrointestinal involvement in Fabry disease by biopsy using endoscope
Scientific Title:Acronym
Gastrointestinal involvement in Fabry disease
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most patients with Fabry disease have intestinal imvolvement. We perform histological and chemical examination by biopsy using endoscope.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immunohistological examination for Gb3, measurement of Gb3 and Lyso-Gb3 by biopsy using endoscope
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
Fabry disease without gastrointestinal symptom
Key exclusion criteria
less than 19 year
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University
Division name
Department of General Internal Medicine
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL
0492761667
imaedahi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Imaeda |
Organization
Saitama Medical University Hospital
Division name
Department of General Internal Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
imaedahi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
IRB committee, Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1111
hirb@saitama-med.ac.jp
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 | 12 | Month | 01 | 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
| 2015 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
immunohistological examination for Gb3, measurement of Gb3 and Lyso-Gb3 by biopsy using endoscope
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
