UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021334 |
|---|---|
| Receipt number | R000024465 |
| Scientific Title | Gene analysis for insulin gene disorders |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2024/03/13 10:11:08 |
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Basic information
Public title
Gene analysis for insulin gene disorders
Acronym
Gene analysis for insulin gene
Scientific Title
Gene analysis for insulin gene disorders
Scientific Title:Acronym
Gene analysis for insulin gene
Region
| Japan |
Condition
Condition
Insulin gene mutations
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Performing the insulin gene analysis to patient and their parents suspected of insulin gene abnormality
Basic objectives2
Others
Basic objectives -Others
gene analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
presence or absence of insulin gene mutations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
taking blood samples
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient and their parents suspected of insulin gene abnormality
Key exclusion criteria
except for patient and their parents suspected of insulin gene abnormality
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University School of Medicine
Division name
Department of Pediatrics
Zip code
9800872
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8574, Japan
TEL
+81-22-717-7287
junkokan@ya2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Hakoda |
Organization
Tohoku University School of Medicine
Division name
Department of Pediatrics
Zip code
9800872
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8574, Japan
TEL
+81-22-717-7287
Homepage URL
akos@mub.biglobe.ne.jp
Sponsor or person
Institute
Department of Pediatrics
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics
Tohoku University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine
Address
1-1 Seiryomachi, Aobaku, Sendai 980-8574, Japan
Tel
022-717-7287
akiko.hakoda.c2@tohoku.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
| 2016 | Year | 03 | Month | 04 | 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
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024465
| 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 |
