UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research into biomarkes for neurodegenerative diseases in peripheral blood and cerebrospinal fluid
Title of the study (Brief title)	Exploratory research into biomarkes for neurodegenerative diseases
Region	Japan

Condition
Condition	Neurodegenerative diseases (especially Parkinson's disease and related disorder, amyotrophic lateral sclerosis)
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish biomarkers available for clinic settings
Basic objectives2	Others
Basic objectives -Others	This is not a research of drug administration
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To identify proteins that is useful for disease 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	target diseases
Key exclusion criteria	nothing particular
Target sample size	180

Research contact person
Name of lead principal investigator	Ryosuke Takahashi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Neurology
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan
TEL	075-751-3111
Email	ryosuket@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shinya Okuda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Neurology
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan
TEL	075-751-3767
Homepage URL
Email	okudas@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The targets will be elected from the patients who consult our department and are diagnosed as Parkinson's disease, related disorder and amyotrophic laterral sclerosis since April 2016 to March 2021. Their cerebrospinal fluid and peripheral blood will be analysed. (The patients is not continuously observed.)

Management information
Registered date	2016 Year 02 Month 26 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024479