UMIN-CTR Clinical Trial

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 Mami Middle name Last name Kanzaki
Organization	Toranomon Hospital Kajigaya
Division name	Department of Neurology
Zip code	213-0015
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 Mami Middle name Last name Kanzaki
Organization	Toranomon Hospital Kajigaya
Division name	Department of Neurology
Zip code	213-0015
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	Toranomon Hospital Kajigaya
Address	1-3-1 Kajigaya, Takatsu-ku, Kawasaki-shi, Kanagawa
Tel	044-877-5111
Email	kakumoto-tky@umin.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	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	0
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	2018 Year 01 Month 09 Day
Date of IRB	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2020 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	inhalted

Management information
Registered date	2018 Year 01 Month 09 Day
Last modified on	2020 Year 07 Month 12 Day

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