UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054567 |
|---|---|
| Receipt number | R000062351 |
| Scientific Title | Comprehensive research with human samples from neurologic diseases |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2024/06/04 18:06:59 |
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Basic information
Public title
Analytic research with clinical samples focusing on nuclear acids, proteins and small molecules from patients with neurologic diseases
Acronym
Analytic research with clinical samples of neurologic diseases
Scientific Title
Comprehensive research with human samples from neurologic diseases
Scientific Title:Acronym
Comprehensive research with human samples from neurologic diseases
Region
| Japan |
Condition
Condition
neurological diseases
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal a molecular pathogenesis based on genome/omics analysis with clinical samples taken from patients with neurological diseases.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of molecular pathways by genome/omics data
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with neurological diseases
Key exclusion criteria
1) If the individual or their legal representative cannot provide written consent based on a full understanding of the purpose of the research.
2) If the attending physician determines that the individual's overall condition is not suitable for sample collection.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | P1_eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.hKdwYXNza2 |
| Last name | Saiki |
Organization
University of Tsukuba Hospital
Division name
Department of Neurology
Zip code
3050005
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
0298533522
ssaiki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | P1_eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.hKdwYXNza2 |
| Last name | Saiki |
Organization
University of Tsukuba
Division name
Department of Neurology, Institute of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533224
Homepage URL
ssaiki@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
0298533522
ssaiki@md.tsukuba.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
| 2024 | Year | 06 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sporadic Parkinson's disease, sporadic Alzheimer's disease: 1000 cases
other diseases: more than 1 case
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062351
