UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052943 |
|---|---|
| Receipt number | R000060114 |
| Scientific Title | investigation of miRNA biomarkers in Osteoarthritis and nociceptive pain |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/02/01 12:29:23 |
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Basic information
Public title
Study to evaluate osteoarthritis and nociceptive pain by measuring microRNA in blood samples
Acronym
KMS-Pain Project
Scientific Title
investigation of miRNA biomarkers in Osteoarthritis and nociceptive pain
Scientific Title:Acronym
KMS-pain biomarker project
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective is to develop biomarkers for osteoarthritis and nociceptive pain so that these can be evaluated with a blood draw.
Basic objectives2
Others
Basic objectives -Others
Blood miRNAs will be measured in three groups: osteoarthritis, femur fracture, and healthy subjects. The expression levels will be compared so that osteoarthritis can be evaluated by blood sampling.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression levels of miRNAs in OA patients and healthy subjects
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
OA group
Indication criteria
1) Patients scheduled for THA due to osteoarthritis of the hip joint.
2) Patients who understand the purpose and content of this study and have given written consent to participate in the study of their own free will.
Fracture group
Indication criteria
1) Patients undergoing surgery for artificial bone replacement due to femur fracture
2) Patients who understand the purpose and content of this study and have given written consent to participate in the study of their own free will.
Normal group
Indication criteria
(1) Patients without pain that has persisted for more than 3 months
2) Patients between 20 and 80 years of age.
(3) Persons who understand the purpose and content of this study and who have given written consent to participate in the study of their own free will.
Key exclusion criteria
OA group
Exclusion criteria
1) Patients with severe pain in a location other than the hip joint (bilateral hip osteoarthritis is not excluded)
2) Patients with severe cognitive dysfunction (delirium, dementia, mental retardation, or other mental decline) at the time of preintervention evaluation.
3) Patients who have difficulty in communicating, reading, and writing in Japanese
4) Other subjects deemed inappropriate for this study by the principal investigator
Fracture group
Exclusion criteria
1) Patients with preoperative severe osteoarthritis of the hip joint
2) Patients with severe cognitive dysfunction (delirium, dementia, mental retardation, or other mental decline) at the time of preintervention evaluation
3) Patients who have difficulty in communicating, reading, and writing in Japanese.
4) Other subjects deemed inappropriate for this study by the principal investigator
Normal group
Exclusion Criteria
1) Patients with illnesses requiring immediate medical treatment
2) Persons with a history of alcohol or drug abuse or those who admit it at this time
3) Persons with a history of manic or psychotic states, or those who admit it at present
4) Persons who have or currently admit to having significant feelings of hopelessness
5) Those with strong cognitive impairment.
6) Those who have difficulty in communicating, reading, and writing in Japanese.
7) Others who the principal investigator deems inappropriate to participate in the research.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishie |
Organization
Kawasaki Medical School
Division name
Department of Anesthesiology and Intensive Care 2
Zip code
701-0192
Address
577 Matsushima Kurashiki Okayama
TEL
086-462-1111
nishiehiroyuki@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishie |
Organization
Kawasaki Medical School
Division name
Department of Anesthesiology and Intensive Care 2
Zip code
7000972
Address
577 Matsushima Kurashiki Okayama
TEL
0564621111
Homepage URL
nishiehiroyuki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
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 Okayama
Tel
084621111
nishiehiroyuki@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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.
Patients and healthy subjects will be recruited between January 1, 2024 and March 31, 2027.
There will be three groups of patients: those with osteoarthritis of the hip joint who have undergone hip replacement surgery, those with femur fractures who have undergone surgery, and healthy subjects.
The primary outcome will be miRNA expression in OA patients and healthy subjects.
The specific miRNA names are not noted. This is because of the patent application.
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060114
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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