UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049112 |
|---|---|
| Receipt number | R000055434 |
| Scientific Title | Exploratory study of plasma HMGB1 dynamics in chronic pain patients with different backgrounds |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2023/11/03 23:16:44 |
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Basic information
Public title
Exploratory study to access the relationship between chronic pain and HMGB1
Acronym
HMGB1 and pain
Scientific Title
Exploratory study of plasma HMGB1 dynamics in chronic pain patients with different backgrounds
Scientific Title:Acronym
CP-HMGB1 study
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the plasma HMGB1 level can be a biomarker for chronic pain patients across diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of plasma HMGB1 level and pain intensity (VAS/BPI)
Key secondary outcomes
Plasma levels (oxytocin, cortisol, cystatin C), psychological evaluation (HADS/PCS), EQ-5D (QOL questionnaire)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients
1) Patients who visit the pain clinic, Department of Anesthesiology, Okayama University Hospital after ethics committee approval to March 31, 2024.
2) Patients who consent to voluntary participate in writing.
3) Patients aged 20 to 90 years at the time of informed consent.
Healthy participants
1) Those who have no pain lasting more than 3 months.
2) Those who are able to obtain written consent from the individual to participate in the research voluntarily.
3) Those who are 20 years old or older and under 90 years old at the time of obtaining consent.
Key exclusion criteria
1) Women who are pregnant or may become pregnant
2) Cancer pain
3) Acute cerebral infarction, acute myocardial infarction, cerebral hemorrhage
4) In addition, patients considered to be inappropriate for the study, the study doesn't benefit for participants, the case that plan evaluation is prevented, limited, or confused, participants are family member of employee, principal investigator, or co-investigator, etc.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morimatsu |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7330
info@okadaimasui.com
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Arakawa |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7330
Homepage URL
pvyw4hhv@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2022 | Year | 10 | Month | 04 | 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
| 2022 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single Prospective Observational Study (Case Control Study) in Okayama University.
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055434
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
