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
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
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
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
