UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051302 |
|---|---|
| Receipt number | R000058439 |
| Scientific Title | Exploratory study for diagnosis of amyotrophic lateral screrosis by metabolome analysis |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/12/08 12:33:03 |
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Basic information
Public title
Exploratory study for diagnosis of amyotrophic lateral screrosis by metabolome analysis
Acronym
Metaborome analysis in ALS
Scientific Title
Exploratory study for diagnosis of amyotrophic lateral screrosis by metabolome analysis
Scientific Title:Acronym
Metaborome analysis in ALS
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the new diagostic biomarker of amyotrophic lateral screrosis by metabolom analysis with the cerebrospinal flood.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The metabolites on amyotrophic lateral sclerosis by metabolom analysis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with amyotrophic lateral sclerosis or periphearal neuropathy
Key exclusion criteria
Patients accompanied with any other neurological diseases
Patinets who do not consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tsuji |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba
TEL
0298533224
htsuji@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tsuji |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba
TEL
0298533224
Homepage URL
htsuji@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Hiroshi Tsuji
Funding Source
Organization
Tohjinkai
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
University of Tsukuba Hospital Clinical Research Ethics Review Committee
Address
2-1-1, Amakubo, Tsukuba, Ibaraki
Tel
029833630
t-credo.adm@un.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
| 2023 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058439
