臨床研究等提出・公開システム

Scientific Title	ALS biomarker research using patient clinical samples
Public Title	ALS biomarker research

Contact for Scientific Queries	Name	Inoue Haruhisa
	Affiliation	Kyoto University
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-366-7360
	E-mail	prj-als_bosutinib@cira.kyoto-u.ac.jp
Contact for Public Queries	Name	Inoue Haruhisa
	Affiliation	Kyoto University
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-366-7360
	E-mail	prj-als_bosutinib@cira.kyoto-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 31, 2019
Actual date of first enrollment		April. 19, 2019
Target sample size		49
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Those who agree to attend the current clinical study among ALS patients joining an accompanying clinical trial "Phase 1/2 Dose Escalation Study of Bostinib in Patients with Amyotrophic Lateral Sclerosis (ALS)"
	Exclusion Criteria	N/A
	Age Minimum	20age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		amyotrophic lateral sclerosis (ALS)
Intervention(s)		collection of cerebrospinal fluid
Health Condition(s) Keyword		ALS
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Alteration of blood biomerkers including SOD1, TDP-43, Src, c-Abl, etc. Alteration of CSF biomerkers including neurofilament L, phosphorylated neurofilament H, SOD1, TDP-43, etc. Alteration of urine biomerkers including p75, etc. Plasma concentration of bosutinib (through value) CSF concentration of bosutinib (through value) Evaluation of biomerkers using iPS cells
Secondary Outcome(s)		N/A

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto University Certified Review Board
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 04, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history