UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047482 |
|---|---|
| Receipt number | R000054149 |
| Scientific Title | Genetic Analysis Research for Gender Identity Disorder |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2025/04/16 09:12:21 |
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Basic information
Public title
Genetic Analysis Research for Gender Identity Disorder
Acronym
Genetic Analysis Research for Gender Identity Disorder
Scientific Title
Genetic Analysis Research for Gender Identity Disorder
Scientific Title:Acronym
Genetic Analysis Research for Gender Identity Disorder
Region
| Japan |
Condition
Condition
Gender Identity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objectives is to elucidate the pathogenesis of gender identity disorders at the genetic level in brain sex differentiation using molecular genetic methods.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The extracted DNA is subjected to whole genome sequencing on a massively parallel high-speed sequencer, and the resulting data is mapped to the human genome sequence. Mutations and polymorphisms are identified using public databases to identify insertions, deletions, non-synonymous substitutions, and mutations affecting splicing, and from the mutations and polymorphisms obtained, mutations and polymorphisms that are enriched in gender identity disorder parties are extracted.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
The group with GID
Interventions/Control_2
normal subjects group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with gender identity disorder by DSM-IV TR.
Key exclusion criteria
The subclassifications of gender identity disorder, bisexual role dress perversion and childhood gender identity disorder, fetishistic dress perversion of different nature, and sex differentiation disorders are excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Kinoshita |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Neuropsychiatry
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki City Osaka
TEL
072-683-1221
shinya.kinoshita@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Kinoshita |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Neuropsychiatry
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki City Osaka
TEL
072-683-1221
Homepage URL
shinya.kinoshita@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University, Department of Neuropsychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki City Osaka
Tel
072-683-1221
rinri@ompu.ac.jp
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
| 2023 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054149
