UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012192 |
|---|---|
| Receipt number | R000014250 |
| Scientific Title | Investigation of biomarkers for assessment of fatigue and stress-associated childhood illnesses. |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2020/11/05 09:18:32 |
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Basic information
Public title
Investigation of biomarkers for assessment of fatigue and stress-associated childhood illnesses.
Acronym
Investigation of biomarkers for assessment of fatigue and stress-associated childhood illnesses.
Scientific Title
Investigation of biomarkers for assessment of fatigue and stress-associated childhood illnesses.
Scientific Title:Acronym
Investigation of biomarkers for assessment of fatigue and stress-associated childhood illnesses.
Region
| Japan |
Condition
Condition
fatigue and stress-associated childhood illnesses
Classification by specialty
| Psychosomatic Internal Medicine | Pediatrics | Psychiatry |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate correlations of fatigue-related factors in blood and saliva and symptoms in fatigue and stress-associated childhood illnesses.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of fatigue-related factors in blood and saliva samples and symptoms in pediatric patients.
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
Pediatric diseases for which fatigue and stress could be risk or aggravating factors.
Key exclusion criteria
Patients with severe physical illnesses, who are judged not suitable by a doctor.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
+81-3-3433-1111
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
+81-3-3433-1111
Homepage URL
kkondo@jikei.ac.jp
Sponsor or person
Institute
Department of Virology,
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Virus Ikagaku Kenkyusho Inc.
IRB Contact (For public release)
Organization
the Ethics Committees of the Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H24-02
Org. issuing International ID_1
Atsugi City Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学葛飾医療センター（東京都）、東京慈恵会医科大学附属第三病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、厚木市立病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0006291X17305739?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0006291X17305739?via%3Dihub
Number of participants that the trial has enrolled
31
Results
We detected higher levels of interleukin (IL)-1 beta and basic fibroblast growth factor (bFGF) in the cerebrospinal fluid (CFS) of patients with HHV-6B encephalitis when compared to those in patients with non-HHV-6B-induced febrile seizures.
Results date posted
| 2019 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 05 | Month | 06 | Day |
Baseline Characteristics
Patients with febrile seizures and encephalitis hospitalized
Participant flow
Because the patients were minors, their legal guardians were presented with an explanation of the procedure, along with informed-consent documentation. After receiving signed consent, blood serum and CSF were collected.
Adverse events
None
Outcome measures
HHV-6B DNA quantities in cerebrospinal fluid (CSF) or serum
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control sampling
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014250
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| Research case data | |
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