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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000029076 |
Receipt No. | 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 |
Basic information | ||
Public title | Development of surrogate end-point biomarkers for chronic fatigue and myalgic encephalmyelitis/chronic fatigue syndrome (
ME/CFS) |
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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) |
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Scientific Title:Acronym | Development of surrogate biomarkers for ME/CFS | |
Region |
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Condition | ||||
Condition | Myalgic encephalomyelitis/chronic fatigue sydnrome (ME/CFS) and healthy control | |||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |