UMIN-CTR Clinical Trial

Basic information
Public title	Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome ( ME/CFS)
Acronym	Development of surrogate biomarkers for ME/CFS
Scientific Title	Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome ( ME/CFS)
Scientific Title:Acronym	Development of surrogate biomarkers for ME/CFS
Region	Japan

Condition
Condition	Myalgic encephalomyelitis/chronic fatigue sydnrome (ME/CFS) and healthy control
Classification by specialty	Medicine in general Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is development of surrogate end-point biomarkers for chronic fatigue syndrome and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Basic objectives2	Others
Basic objectives -Others	Development of biomarkers-case-control study
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The level of brain positive inflammation dected by positron emission tomography (PET), [F18]DPA-714
Key secondary outcomes	Oxidative stress level, Anti-oxidant activity, Metabolome, Proteome, Cytokines, Extracellular vesicles, Clinical test (CRP, cholesterol, etc.), CD antibody, Autonomic nervous system, Questionnaires for fatigue, depression and various symptoms, Arithmetic task, Sleep-wake cycle, Performance status for fatigue

Base
Study type	Others,meta-analysis etc

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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Meet diagnosis both CDC criteria (1994) and ME/CFS (2003)
Key exclusion criteria	1) Pregnant women, those who are likely to become pregnant, those who are breastfeeding 2) Person who has metal, pacemaker in the body by surgery etc. 3) Claudophobia 4) Persons who have a history of feeling sick during blood sampling 5) Persons who are experiencing psychiatric diseases before suffering chronic fatigue syndrome 6) Person who has fatigue performance status less than 4 7) A person who falls under the exclusionary disorder in ME/CFS clinical diagnostic criteria(2016) of the Ministry of Health, Labor and Welfare, a person who has undergone diagnosis of cerebral spinal fluid reduction 8) Until three month's earlier PET examination, persons who are unable to stop taking drug which may affect microglial activation or Chinese medicine with anti-inflammatory effects 9) Until one month prior to the implementation of PET, persons who are unable to stop medicines that may affect microglia activation or high antipyretics analgesic drugs with COX-1 selection system 10) BMI less than 15, more than 30 11) Others who judged inappropriate by the attending physician 12) For healthy subjects, those with a history of anemia, those with chronic fatigue and malaise, those with a history of surgery within six months, those with a history of psychiatric diseases, workers with working over 100 hours per month or shift worker with night shift, person with sleep disorder, person who has been reexamined by health check within 6 months, more than 2 in fatigue performance status
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yasuyoshi Middle name Last name Watanabe
Organization	Osaka City University
Division name	Graduate School of Medicine
Zip code	5458585
Address	1-4-3, Asahimachi, Abenoku, Osaka City
TEL	06-6646-2311
Email	yywata@riken.jp

Public contact
Name of contact person	1st name Hirohiko Middle name Last name Kuratsune
Organization	Osaka City University
Division name	Graduate School of Medicine
Zip code	5458585
Address	1-4-3, Asahimachi, Abenoku, Osaka City
TEL	06-6646-3033
Homepage URL
Email	kura@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	RIKEN, Kyushu University, Yamaguchi University, Kansai University of Welfare Sciecnes, Nakatomi Fatigue Care Clinic, MI Clinic, Mie University, Astellas
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Osaka City University Graduate School of Medicine
Address	1-2-7 Abenomedix 6F, Asahimachi, Osaka Shi Abeno Ku, Osaka Fu
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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	大阪市立大学医学部付属病院（大阪府）、ナカトミファティーグケアクリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 12 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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 29 Day
Date of IRB	2017 Year 07 Month 31 Day
Anticipated trial start date	2017 Year 09 Month 14 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2017 Year 09 Month 10 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033257

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.