UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032416 |
|---|---|
| Receipt number | R000036961 |
| Scientific Title | Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2024/05/03 16:20:31 |
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Basic information
Public title
Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Acronym
Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Scientific Title
Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Scientific Title:Acronym
Development of objective diagnostic and evaluation tool for chronic primary pain by serum miRNA and cell free DNA
Region
| Japan |
Condition
Condition
chronic primary pain
Classification by specialty
| Psychiatry | Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To make an objective diagnostic and evaluation tool for chronic primary pain
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum miRNA alterations before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
cognitive behavior therapy
Interventions/Control_2
total hip arthroplasty
Interventions/Control_3
healthy control
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients with pain over 3 months
2) 20 to 80 years old
3) consent to participate the study
Key exclusion criteria
1) patients with acute disease
2) alcohol or drug abuse
3) psychogenic disorder
4) suicidal thought
5) cognitive disorder
6) patients who do not speak Japanese
7) trauma
8) seeking compensation
9) pain rating is 10
10) contraindication for MRI
11) Those who have judged inappropriate for this research
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishie |
Organization
Kawasaki Medical School Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
7010192
Address
577 Matsushima Kurashiki Japan
TEL
0864621111
nishiehiroyuki@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishie |
Organization
Kawasaki Medical School Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
7010192
Address
577 Matsushima Kurashiki Japan
TEL
086-462-1111
Homepage URL
nishiehiroyuki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima Kurashiki
Tel
0864621111
kenkyu-idai1@med.kawasaki-m.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-17K09049/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-17K09049/
Number of participants that the trial has enrolled
42
Results
Some miRNAs were tested in some samples by microarray to look for candidates. In addition, RT-PCR was performed for a total of 11 miRNAs together with the miRNAs reported in the paper. 2 of the 11 miRNAs had very low expression levels, so 9 were scrutinized. Of these, we found one that was expressed at a lower level before THA surgery compared to CPP and the healthy group, and whose expression increased after THA surgery.
Results date posted
| 2024 | Year | 05 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
patent pending
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036961
