UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038404 |
|---|---|
| Receipt number | R000043765 |
| Scientific Title | Sensitivity and specificity of current diagnostic criteria in prion diseases and suspected prion diseases |
| Date of disclosure of the study information | 2019/10/28 |
| Last modified on | 2024/05/05 15:14:00 |
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Basic information
Public title
Sensitivity and specificity of current diagnostic criteria in prion diseases and suspected prion diseases
Acronym
Sensitivity and specificity of current diagnostic criteria in patients with prion disease
Scientific Title
Sensitivity and specificity of current diagnostic criteria in prion diseases and suspected prion diseases
Scientific Title:Acronym
Sensitivity and specificity of current diagnostic criteria in patients with prion disease
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
prion disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the sensitivity and specificity of current diagnostic criteria for prion diseases in patients of prion diseases
Basic objectives2
Others
Basic objectives -Others
Revision of diagnostic criteria
Validation of the diagnostic criteria at hospitalization and 1 month
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of diagnostic criteria at admission
Key secondary outcomes
Sensitivity and specificity of diagnostic criteria one month after hospitalization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
MRI
CSF analysis
EEG
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
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients who have undergone neurology in each research university between the institution's permission date and March 31, 2021
(2)Target diseases: Neurodegenerative diseases including prion diseases (Creutzfeldt-Jakob disease (CJD), Gerstmann-Streisler-Scheinker syndrome (GSS), lethal familial insomnia (FFI)), epilepsy, Alzheimer type dementia), Diseases with rapidly progressive dementia
(3)Age: 20 years old or older
(4)Gender: regardless of gender.
(5)Patients who have received sufficient explanation for participation in this study, and who have fully understood and consented to the document of their own (or substitute).
Key exclusion criteria
(1)If the research subject and research subject offer to cancel the study within the hospitalization period.
(2)Other patients who are deemed inappropriate by the researchers as research subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Satoh |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City 852-8501, Japan
TEL
095-819-7991
satoh-prion@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Satoh |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Japan
TEL
095-819-7991
Homepage URL
http://www2.am.nagasaki-u.ac.jp/prion-cjd/research/
satoh-prion@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Locomotive Rehabilitation Science, Unit of Rehabilitation Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Katsuya Satoh
Funding Source
Organization
Japan Medical Research and Development Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Health Sciences (Neurology), Graduate School of Biomedical Sciences, Nagasaki University
National Center of Neurology and Psychiatry Hospital
Department of Neurodegeneration and Neurological Disorders (Neurology), Graduate School of Medical Sciences, Kanazawa University
Department of Ultra High-Field MRI Diagnosis and Disease Pathophysiology, Institute for Biomedical Sciences, Iwate Medical University
Department of Neurology and Neurological Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Department of Neurology, Faculty of Medicine, Fukuoka University
Department of Neurology and Stroke Medicine, International Medical Center, Saitama Medical University
Institute of Advanced Medicine for Aging, Aichi Medical University
Department of Genetic Function Analysis, Resource Branch, Brain Research Institute, Niigata University (Transdisciplinary Research Organization)
Department of Neurology, Yokohama City University Medical Center
Department of Neurology, Medical Sciences Cluster, Interdisciplinary Graduate School, University of Yamanashi
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Life and Medical Sciences, Research Office, General Affairs Division (Research Support)
Address
1-12-4 Sakamoto, Nagasaki City
Tel
095-819-7991
yoshi-t@nagasaki-u.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
| 2019 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
http://www2.am.nagasaki-u.ac.jp/prion-cjd/research/
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 31 | Day |
Other
Other related information
We are requesting an extension due to lack of cases.
It is unclear how long the extension will be due to the fact that there are currently patients who wish to have an autopsy. On the other hand, we are in the process of submitting a manuscript for publication.
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
