UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035081 |
|---|---|
| Receipt number | R000039995 |
| Scientific Title | Quantitative blood-brain barrier permeability and susceptibility mapping for patients with CADASIL and suspected to have CADASIL |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/06/03 10:09:11 |
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Basic information
Public title
Quantitative blood-brain barrier permeability and susceptibility mapping for patients with CADASIL and suspected to have CADASIL
Acronym
BBB permeability and QSM for CADASIL
Scientific Title
Quantitative blood-brain barrier permeability and susceptibility mapping for patients with CADASIL and suspected to have CADASIL
Scientific Title:Acronym
BBB permeability and QSM for CADASIL
Region
| Japan |
Condition
Condition
CADASIL
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To quantify blood-brain barrier permeability and susceptibility value in patients with CADASIL, using MRI.
Basic objectives2
Others
Basic objectives -Others
To compare the values with non-CADASIL patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantification of blood-brain barrier permeability and susceptibility value in patients with CADASIL
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with CADASIL and their family
Key exclusion criteria
Patients who are prohibited to take MRI
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya city university
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
0528538094
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
0528538094
Homepage URL
uchidayuto0720@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya City University
Address
1 Kawasumi, Mizuho-ku, Nagoya
Tel
0528538094
uchidayuto0720@yahoo.co.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
| 2018 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional/longitudinal observational study
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039995
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
