UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045255 |
|---|---|
| Receipt number | R000051656 |
| Scientific Title | Genetic Analysis Study of Neurosurgical Diseases |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/25 09:50:48 |
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Basic information
Public title
Genetic Analysis Study of Neurosurgical Diseases
Acronym
GASND
Scientific Title
Genetic Analysis Study of Neurosurgical Diseases
Scientific Title:Acronym
GASND
Region
| Japan |
Condition
Condition
Cerebral aneurysms, cerebral arteriovenous malformations, epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation of causative genes, disease susceptibility genes, and modifier genes in neurosurgical diseases (cerebrovascular disorders, epilepsy)
Basic objectives2
Others
Basic objectives -Others
Neurosurgical procedures allow to obtain tissue samples from pathological brain and vascular structures and be submitted to genetic analysis. Such samples, complemented with post-mortem samples from neurosurgical patients and parallel blood samples makes possible the identification of somatic mutations related to important neurosurgical conditions and investigation of their expression.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Elucidate disease pathogenesis by identifying disease-causing, disease-susceptibility, and modifying genetic mutations.
Key secondary outcomes
Paired tissue and blood analysis can reveal the presence of somatic mutations that are important for pathogenesis.
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
1) Patients with established diagnosis of cerebrovascular disease and epilepsy and a control group (patients who were treated for conditions other than the target diseases) will be included in the analysis. If intrafamilial clustering or inherited disease is strongly suspected, and the importance and validity of linkage analysis are considered to be very high, family members (siblings, parents, children, other relatives etc.) will be included in the analysis of this study.
2) Patients who have visited an affiliated to the study hospital that was approved by the Ethics Committee to conduct the study.
3) Regardless of age or gender.
4) Adults who have given their written consent. Minors under 20 years of age or patients with cerebrovascular diseases and epilepsy who cannot be held legally responsible will require a consent of their parents or guardians.
Key exclusion criteria
Exclude cases where the above eligibility criteria are not met.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Nakatomi |
Organization
RIKEN
Division name
Center for Brain Science, Biomedical neural dynamics collaboration laboratory
Zip code
351-0198
Address
2-1, Hirosawa, Wako-shi, Saitama, Japan
TEL
048-467-9266
hirofumi.nakatomi@riken.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Nakatomi |
Organization
RIKEN
Division name
Center for Brain Science, Biomedical neural dynamics collaboration laboratory
Zip code
351-0198
Address
2-1, Hirosawa, Wako-shi, Saitama, Japan
TEL
048-467-9266
Homepage URL
hirofumi.nakatomi@riken.jp
Sponsor or person
Institute
RIKEN Center for Brain Science
Institute
Department
Personal name
Funding Source
Organization
RIKEN Center for Brain Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics First Committee Bureau (Safety Management Department Biosafety Division)
Address
2-1, Hirosawa, Wako-shi, Saitama 351-0198, Japan RIKEN
Tel
048-467-9266
human@riken.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
札幌禎心会病院（北海道）、東京大学医学部附属病院（東京都）、杏林大学医学部附属病院（東京都）、富永病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to elucidate the pathogenesis of some most common neurosurgically treated diseases (cerebrovascular disorders, epilepsy) by identifying causative, disease susceptibility, and modifier genetic mutations.
The ability to obtain directly specimens of diseased intracranial and brain structures during neurosurgical operations for cerebrovascular disease and epilepsy is a unique opportunity to investigate these structures. Investigated together with parallel blood samples and collecting autopsy specimens can allow extensive genetic analysis for the presence of somatic mutations in potential causative relation to the investigated neurological diseases. In the cerebrovascular diseases domain, the main focus will be on cerebral aneurysms that lead to frequent disability and death after rupture, and cerebral arteriovenous malformations, which also often cause hemorrhage, epilepsy and ischemia.
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051656
