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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013245
Receipt No. R000015091
Scientific Title The study of ALS biomarker based on molecular dynamics of oxidative stress regulatory factor
Date of disclosure of the study information 2014/02/25
Last modified on 2015/03/30

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Basic information
Public title The study of ALS biomarker based on molecular dynamics of oxidative stress regulatory factor
Acronym ALS biomarker research
Scientific Title The study of ALS biomarker based on molecular dynamics of oxidative stress regulatory factor
Scientific Title:Acronym ALS biomarker research
Region
Japan

Condition
Condition Amyotrophic lateral sclerosis
Parkinson's disease
Multiple sclerosis
Healthy individuals
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The verification of the usefulness of oxidative stress regulatory factor as the ALS biomarker using blood sample from ALS patients
Basic objectives2 Others
Basic objectives -Others In order to analyze whether quantitative alteration of oxidative stress regulatory factor is specific in ALS, blood sample from healthy individuals and patients with Parkinson's disease and multiple sclerosis as controls would be also analyzed.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exploration of novel biomarker
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
71 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed as having ALS and satisfying all of the following criteria.
1)ALS patients who are diagnosed by EL Escorial revised Airlie House criteria as clinically definite,clinically probable or clinically probable-laboratory-supported, clinically pssible ALS or clinically suspected ALS, and Stage I, II or III in ALS severity classification.
2)Older than 20 and younger than 71 years old
3)Patients who give informed consent after detailed explanation of the study

As disease controls, PD or MS patients satisfying all of the following criteria.
1)Older than 20 and younger than 71 years old
2)Patients who consulted a nerve outpatient and obtained consent for study entry
3)Patients who give informed consent after detailed explanation of the study

Healthy individuals satisfying all of the following criteria.
1)Older than 20 and younger than 71 years old
2)Healthy individuals who have interest in this study
3)Healthy individuals who give informed consent after detailed explanation of the study
Key exclusion criteria 1)Patient to whom the diagnosis has not been disclosed
2)Patient having severe psychiatric symptoms (hallucination, delusion) or dementia
3)Patient having serious orthostatic hypotension or other types of hypotension
4)Patient having a severe complication(s) such as heart, kidney and/or liver disease
5)Patient having the complications of the allergic disease that an acidophile level is easy to rise
6)Patient did not have ability to comprehend informed consent
7)Patient who was inappropriate for this study
8)Patient who has received an investigational drugs or devices within three months before
9) Patient who participates in other clinical trials
*The patient treated with existing therapeutic drug does not correspond to exclusion criteria
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Joh-E Ikeda
Organization Faculty of Medicine, Kitasato University
Division name Department of Molecular Neurology
Zip code
Address 1-15-1, Kitasato, Minami, Sagamihara, Kanagawa 252-0374, Japan
TEL 042-778-9441
Email alspd@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Tanaka
Organization Faculty of Medicine, Kitasato University
Division name Department of Molecular Neurology
Zip code
Address 1-15-1, Kitasato, Minami, Sagamihara, Kanagawa 252-0374, Japan
TEL 042-778-9441
Homepage URL
Email alspd@med.kitasato-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kitasato University
Institute
Department

Funding Source
Organization Faculty of Medicine, Kitasato University
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
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 25 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 Completed
Date of protocol fixation
2013 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study to establish biomarker for disease progression in ALS. As control groups, healthy individuals, patients with Parkinson's disease and multiple sclerosis would be analyzed.

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2015 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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