UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007139 |
|---|---|
| Receipt number | R000008393 |
| Scientific Title | Epigenetic analyses of pervasive developmental disorders |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/01/26 09:44:12 |
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Basic information
Public title
Epigenetic analyses of pervasive developmental disorders
Acronym
Epigenetic analyses of pervasive developmental disorders
Scientific Title
Epigenetic analyses of pervasive developmental disorders
Scientific Title:Acronym
Epigenetic analyses of pervasive developmental disorders
Region
| Japan |
Condition
Condition
pervasive developmental disorders
Williams Syndrome
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze epigenetic profiles of patients with pervasive developmental disorders
Basic objectives2
Others
Basic objectives -Others
Genetic or epigenetic analyses
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Genetic or epigenetic profiles of pervasive developmental disorders
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pervasive developmental disorders or Williams syndrome, who or whose parents gave written informed consent.
Key exclusion criteria
Subjects with other mental/ neurodegenerative diseases.
Subjects whose doctor in charge does not agree to join the research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Hagiwara |
Organization
Graduate School of Medicine
Kyoto University
Division name
Anatomy and Developmental Biology
Zip code
Address
Yoshida-Konoecho, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Hagiwara |
Organization
Graduate School of Medicine
Division name
Anatomy and Developmental Biology
Zip code
Address
Yoshida-Konoecho, Sakyo-ku, Kyoto
TEL
075-753-4341
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze epigenetic profiles of patients with pervasive developmental disorders
Management information
Registered date
| 2012 | Year | 01 | Month | 26 | Day |
Last modified on
| 2012 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008393
