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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029076
Receipt No. R000033257
Official scientific title of the study Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome ( ME/CFS)
Date of disclosure of the study information 2017/09/12
Last modified on 2018/02/06

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Basic information
Official scientific title of the study Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome (
ME/CFS)
Title of the study (Brief title) 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) Persons who are unable to stop taking benzodiazepines, non benzodiazepines, by the day of PET examination at the discretion of the doctor
9) 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
10) 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
11) BMI less than 15, more than 30
12) Others who judged inappropriate by the attending physician
13) 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 Yasuyoshi Watanabe
Organization Osaka City University
Division name Graduate School of Medicine
Address 1-4-3, Asahimachi, Abenoku, Osaka City
TEL 06-6646-2311
Email yywata@riken.jp

Public contact
Name of contact person Hirohiko Kuratsune
Organization Osaka City University
Division name Graduate School of Medicine
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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 29 Day
Anticipated trial start date
2017 Year 09 Month 14 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 None

Management information
Registered date
2017 Year 09 Month 10 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.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


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