UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013111 |
|---|---|
| Receipt number | R000015297 |
| Scientific Title | Identification of the new biomarkers of amyotrophic lateral sclerosis |
| Date of disclosure of the study information | 2014/02/12 |
| Last modified on | 2018/07/09 12:54:09 |
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Basic information
Public title
Identification of the new biomarkers of amyotrophic lateral sclerosis
Acronym
Identification of the new biomarkers of amyotrophic lateral sclerosis
Scientific Title
Identification of the new biomarkers of amyotrophic lateral sclerosis
Scientific Title:Acronym
Identification of the new biomarkers of amyotrophic lateral sclerosis
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will investigate the biomarkers for ALS patients through calculating the blood and serum concentrations of aminoacids and proteins.
Basic objectives2
Others
Basic objectives -Others
Identification and analysis of the biomarkers for ALS
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify the useful biomarkers which are correlated to the clinical course and the disease state of ALS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those patients who received diagnosis of ALS and joined to JaCALS which is a cohort study of ALS.
Key exclusion criteria
The patients who have the multiple neurodegenerative diseases.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Naogya
TEL
052-744-2391
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ikenaka |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Naogya
TEL
052-744-2391
Homepage URL
ikenakaman@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Neurology, Department of Medicine, Jichi Medical school
National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Department of Neurology, Mie University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 02 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are investigating whether the blood or CSF concentration of ADMA are correlated with the disease sevearity or disease course.
Management information
Registered date
| 2014 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015297
