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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013111
Receipt No. 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

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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
Email 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
Email ikenakaman@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate school of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015297

Research Plan
Registered date File name
2018/07/09 ADMAstudy_20180706.xlsx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/07/09 ADMAstudy_20180706.xlsx


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