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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007139
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Graduate School of Medicine
Kyoto University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008393

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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