UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study for pain and cognitive impairment
Acronym	Prospective observational study for pain and cognitive impairment
Scientific Title	Prospective observational study for pain and cognitive impairment
Scientific Title:Acronym	Prospective observational study for pain and cognitive impairment
Region	Japan

Condition
Condition	Diseases with pain and/or cognitive impairment
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploring biomarkers of pain and congitive impairment
Basic objectives2	Others
Basic objectives -Others	Exploring biomarkers of pain and congitive impairment
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical usefulness of biomarkers of pain and cognitive impairment
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	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	our patients
Key exclusion criteria	refusal by patients
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Sumitani
Organization	The University of Tokyo Hospital
Division name	Dept. Pain and Palliative Medicine
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 Hospital
Division name	Dept. Pain and Palliative Medicine
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 Hospital Dept. Pain and Palliative Medicine
Institute
Department

Funding Source
Organization	The University of Tokyo Hospital Dept. Pain and Palliative Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo Hospital, Dept. Pain and Palliative Medicine
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	2019 Year 08 Month 16 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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 07 Month 20 Day
Anticipated trial start date	2019 Year 08 Month 14 Day
Last follow-up date	2029 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Exploring biomarkers of pain and cognitive impairment

Management information
Registered date	2019 Year 08 Month 16 Day
Last modified on	2019 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042965