UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053097 |
|---|---|
| Receipt number | R000060590 |
| Scientific Title | Survey for therapeutic results of Gamma Knife Radiosurgery for brain arteriovenous malformations in Hereditary Hemorrhagic Telangiectacia |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2023/12/13 21:44:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey for therapeutic results of Gamma Knife Radiosurgery for brain arteriovenous malformations in Hereditary Hemorrhagic Telangiectacia
Acronym
Therapeutic results of GKR for HHT-AVM
Scientific Title
Survey for therapeutic results of Gamma Knife Radiosurgery for brain arteriovenous malformations in Hereditary Hemorrhagic Telangiectacia
Scientific Title:Acronym
Survey for therapeutic results of GKR for brain AVM in HHT
Region
| Japan |
Condition
Condition
brain arteriovenous malformation, hereditary hemorrhagic telangiectacia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the therapeutic results of Gamma Knife Radiosurgery for brain arteriovenous malformations in HHT patients in Japan to elucidate their characteristics, effectiveness, and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy : Occlusion status of brain arteriovenous malformations, timing of occlusion, rate of bleeding, rate of retreatment.
adverse events: Symptomatic and asymptomatic events, seizures, neurological symptoms."
Key secondary outcomes
Imaging changes: Cerebral edema (extent, time to resolution), cyst formation, and others."
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 Diagnosis of brain arteriovenous malformation has been obtained through cerebral angiography, CT angiography, and MRI.
2 Gamma Knife treatment has been performed for the brain arteriovenous malformation between January 1, 2003, and May 30, 2021.
3 The medical history or diagnosis includes "multiple brain arteriovenous malformations," "Osler's disease," "HHT (hereditary hemorrhagic telangiectasia)," "hereditary hemorrhagic telangiectasia," and "hereditary peripheral telangiectasia."
Key exclusion criteria
1 Patients with insufficient medical information.
2 Patients deemed unsuitable for conducting this investigation by the principal investigator or research collaborators.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Akiyama |
Organization
Keio University, school of medicine
Division name
Department of Neurosurgery,
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
akiyamanor@keio.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Akiyama |
Organization
Keio University, school of medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
Homepage URL
akiyamanor@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Takenori Akiyama
Funding Source
Organization
nothing
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
Keio University, ethics committee
Address
35 shinanomachi, Shinjuku, Tokyo, Japan
Tel
0333531211
https://www.ctr.med.keio.ac.jp/forms/
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 | 12 | Month | 14 | 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
45
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collecting data from Gamma Knife facilities as collaborative research institutions, investigating and analyzing patient profiles, treatment progress, and post-treatment outcomes of HHT-AVM using survey forms.
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
