UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029076 |
|---|---|
| Receipt number | R000033257 |
| Scientific Title | 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 | 2020/03/13 10:29:34 |
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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
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
kura@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033257
