UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016855 |
|---|---|
| Receipt number | R000018989 |
| Scientific Title | Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2024/05/05 15:56:41 |
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Basic information
Public title
Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease
Acronym
Research for biomarkers of serum/CSF in patients with rapidly progressive dementia
Scientific Title
Research for biomarkers of serum/CSF in patients with rapidly progressive dementia including human prion disease
Scientific Title:Acronym
Research for biomarkers of serum/CSF in patients with rapidly progressive dementia
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
Condition
Condition
rapidly progressive dementia including human prion disease
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify a causative agent using living body materials for an intervital patient diagnosed as being progressive rapidly and establish the biomarker and protein detection method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of biomarkers among the 1500 cases during three years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
one year 500 cases
three years 1500 cases
472 cases nominated from April 2015 to March 2016.
And 492 cases nominated from April 2016 to March 2017.
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
The cases suspected rapidly progressive dementia including prion disease
Key exclusion criteria
none
Target sample size
1500
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
852-8520
Address
1-12-4 Sakamoto, Nagasaki
TEL
095-819-7059
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
TEL
095-819-7991
Homepage URL
http://www.med.nagasaki-u.ac.jp/mmi/cmb/prion/index.html
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
Funding Source
Organization
Research Group on surveillance and infection prevention of prion disease
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto, Nagasaki Prefecture
Tel
095-819-2054
gakujutu_gakuji@ml.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
長崎県長崎市坂本1-7-1保健学科棟5階
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
100000
Results
Of the 500 patients with prion disease or suspected prion disease to date, 102 have been diagnosed with prion disease at follow-up. It is now clear that the positive rate of current biomarkers and other RT-QUIC methods is 70-80%. Further study is needed to accumulate more cases.
Results date posted
| 2024 | Year | 05 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Not only the shortage of cases but also many new detection methods have been reported. Because I feel that the effectiveness of the method is being examined.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 12 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
498 cases were enrolled annually from April 2016 to March 2017.
Management information
Registered date
| 2015 | Year | 03 | Month | 20 | 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=R000018989
