UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019166
Receipt number R000022161
Scientific Title Genomic study for developmental disorders and treatment response and side effects
Date of disclosure of the study information 2015/10/01
Last modified on 2019/10/03 13:06:28

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Basic information

Public title

Genomic study for developmental disorders and treatment response and side effects

Acronym

Genomic study for developmental disorders

Scientific Title

Genomic study for developmental disorders and treatment response and side effects

Scientific Title:Acronym

Genomic study for developmental disorders

Region

Japan


Condition

Condition

Developmental disorders including pervasive developmental disorder and attention deficit hyperactivity disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The objectives of this study are to identify genetic variants associated with developmental disorders and to elucidate their pathophysiology and finally find cures and prevention for them.

Basic objectives2

Others

Basic objectives -Others

genomic analysis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Genetic variants

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

3 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with diagnosis of developmental disorders, their family members, and healthy controls.

Key exclusion criteria

None.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Ozaki

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2282

Email

ozaki-n@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Itaru Kushima

Organization

Nagoya University

Division name

Graduate School of Medicine

Zip code


Address

Showaku, Tsurumai-cho 65, Nagoya

TEL

052-744-2282

Homepage URL


Email

kushima@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

MEXT and AMED

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

2015 Year 10 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

2006 Year 01 Month 18 Day

Date of IRB

2006 Year 02 Month 13 Day

Anticipated trial start date

2006 Year 02 Month 13 Day

Last follow-up date

2019 Year 08 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Case control study
Recruiting patients with a diagnosis of developmental disorders in Nagoya university and its related hospitals.
Genomic analysis


Management information

Registered date

2015 Year 09 Month 30 Day

Last modified on

2019 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022161


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name