UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008503
Receipt number R000009996
Scientific Title Epigenetic analysis of developmental disorders
Date of disclosure of the study information 2012/07/23
Last modified on 2012/07/23 20:21:36

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Basic information

Public title

Epigenetic analysis of developmental disorders

Acronym

Epigenetic analysis of developmental disorders

Scientific Title

Epigenetic analysis of developmental disorders

Scientific Title:Acronym

Epigenetic analysis of developmental disorders

Region

Japan


Condition

Condition

Williams syndrome, Rett syndrome

Classification by specialty

Pediatrics Psychiatry Adult
Child

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To analyze epigenetic profiles of patients with developmental disorders

Basic objectives2

Others

Basic objectives -Others

Genetic or epigenetic analysis

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Genetic or epigenetic profiles of 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 developmetal disorders (Williams syndrome, Rett syndrome), who or whose patients gave written informed consent.

Key exclusion criteria

Subjects with other mental / neurodegenerative diseases.
Subjects whose doctor in charge dose not agree to join the research.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoshi Hagiwara

Organization

Kyoto University
Graduate School of Medicine

Division name

Anatomy and Developmental Biology

Zip code


Address

Yoshida-Konoecho, Sakyo-ku, Kyoto

TEL

075-753-4341

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masatoshi Hagiwara

Organization

Kyoto University 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 or person

Institute

Kyoto University
Graduate School of Medicene

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


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

京都大学医学部附属病院(京都府)
大阪市立総合医療センター(大阪府)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 23 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 07 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 08 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 developmental disorders


Management information

Registered date

2012 Year 07 Month 23 Day

Last modified on

2012 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009996


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name