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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030729
Receipt No. R000035087
Scientific Title Association between genotype and clinical course of amyotrophic lateral sclerosis
Date of disclosure of the study information 2018/01/25
Last modified on 2018/01/25

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Basic information
Public title Association between genotype and clinical course of amyotrophic lateral sclerosis
Acronym Association between genotype and clinical course of amyotrophic lateral sclerosis
Scientific Title Association between genotype and clinical course of amyotrophic lateral sclerosis
Scientific Title:Acronym Association between genotype and clinical course of amyotrophic lateral sclerosis
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effect of gender mutation and clinical information in patients with familial amyotrophic lateral sclerosis and the effects of edaravone and riluzole.
Basic objectives2 Others
Basic objectives -Others natural history
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the relationship between gene mutation and information on medical record. Information on the medical record includes information on age, sex, height, weight, past history, age of onset, onset form, diagnosis findings and aging, ALSFRS-R (ALS function evaluation scale), riluzole and edaravone.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are diagnosed as ALS, genetic analysis is performed with the review of the ethical committee on the human genome and genetic analysis research and approval of the hospital director, and patients with mutations in known genes
Key exclusion criteria Cases for which patients or the legal representatives did not agree are excluded. Patients who did not have gene mutation as a result of genetic analysis examination are excluded.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mami Kanzaki
Organization Toranomon Hospital Kajigaya
Division name Department of Neurology
Zip code
Address 1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL 044-877-5111
Email mami.kanzaki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mami Kanzaki
Organization Toranomon Hospital Kajigaya
Division name Department of Neurology
Zip code
Address 1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
TEL 044-877-5111
Homepage URL
Email mami.kanzaki@gmail.com

Sponsor
Institute Toranomon Hospital Kajigaya
Institute
Department

Funding Source
Organization Okinaka memorial institute for medical research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor The University of Tokyo Hospital
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 虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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 Before the test begins

Management information
Registered date
2018 Year 01 Month 09 Day
Last modified on
2018 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035087

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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