UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003301 |
|---|---|
| Receipt number | R000003962 |
| Scientific Title | Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients |
| Date of disclosure of the study information | 2012/03/31 |
| Last modified on | 2024/05/05 15:33:25 |
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Basic information
Public title
Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Acronym
Analysis of efficacy of markers in CSFof prio disease patients
Scientific Title
Analysis of efficacy of biochemical markers and the method of the detection of abnormal prion protein in CSF of prio disease patients
Scientific Title:Acronym
Analysis of efficacy of markers in CSFof prio disease patients
Region
| Japan |
Condition
Condition
prion disease
Classification by specialty
| Medicine in general | Neurology | Infectious disease |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of biochemical makers and Usefulness of the detective method of abnormal prion protein of CSF in prion disease patients
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
the diagnostic markers of prion disease
Key secondary outcomes
the sensitivity and the specificity
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
prion disease patients
Key exclusion criteria
non-prion disease patients
Target sample size
40
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 Molecular Microbiology and Immunology
Zip code
852-8102
Address
1-12-4 Sakamoto, Nagasaki
TEL
09049918364
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 Molecular Microbiology and Immunology
Zip code
852-8102
Address
1-12-4 Sakamoto, Nagasaki
TEL
09049918364
Homepage URL
satoh-prion@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Katsuya Satoh
Funding Source
Organization
Japan Society for the Promotion of Science
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
Academic Affairs Section, Academic Cooperation Division, Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki
Tel
095-819-7200
095-819-7200
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
| 2012 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
3418
Results
We had analyzed for the sensitivity and specificity of biomarkers and RT-QUIC method. We are going to report them by the manuscript in 2015.
Results date posted
| 2024 | Year | 05 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is taking a long time to be accepted.
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 30 | Day |
Other
Other related information
retrospective study to reveal the rate of biochemical marker and the usefulness of the detcteion of abnormal prion protein in CSF of prio disease patients.
Management information
Registered date
| 2010 | Year | 03 | Month | 08 | 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=R000003962
