UMIN-CTR Clinical Trial

Basic information
Public title	Biomarkers of pain
Acronym	Biomarkers of pain
Scientific Title	Biomarkers of pain
Scientific Title:Acronym	Biomarkers of pain
Region	Japan

Condition
Condition	pain diseases
Classification by specialty	Medicine in general Neurology Surgery in general Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	exploring pain biomarkers
Basic objectives2	Others
Basic objectives -Others	objective evaluation of psychosomatic aspects of pain
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	usefulness of pain biomarkers
Key secondary outcomes	psychosomatic aspects of pain

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	pain diseases
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Sumitani
Organization	The University of Tokyo
Division name	Hospital
Zip code	113-0033
Address	Hongo 7-3-1, Bunkyo, Tokyo
TEL	03-3815-5411
Email	sumitanim-ane@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Sumitani
Organization	The University of Tokyo
Division name	Hospital
Zip code	113-0033
Address	Hongo 7-3-1, Bunkyo, Tokyo
TEL	03-3815-5411
Homepage URL
Email	sumitanim-ane@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	The University of Tokyo
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	The University of Tokyo
Address	Hongo 7-3-1, Bunkyo, Tokyo
Tel	03-3815-5411
Email	sumitanim-ane@h.u-tokyo.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 04 Month 07 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 01 Day
Date of IRB	2022 Year 03 Month 31 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2032 Year 06 Month 30 Day
Date of closure to data entry	2032 Year 06 Month 30 Day
Date trial data considered complete	2032 Year 06 Month 30 Day
Date analysis concluded	2033 Year 03 Month 31 Day

Other
Other related information	none

Management information
Registered date	2022 Year 04 Month 06 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054075