UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of Objective Performance Status by networkable thermal sensors
Acronym	Establishment of Objective Performance Status
Scientific Title	Establishment of Objective Performance Status by networkable thermal sensors
Scientific Title:Acronym	Establishment of Objective Performance Status
Region	Japan

Condition
Condition	All hospitalized patients
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Because of the shortage of medical resources, there is a strong doubt if the performance status (PS) is adequately evaluated under the present situation, even PS plays as a critical factor to decide treatments.The goal of our research is to establish objective PS by using multiple networkable thermal sensors gathering the data of movement and analysis from distant places.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Performance Status
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The period:all hospitalization period after informed consent The amount and frequency of intervention: continuous monitoring for all period The contents:thermal distribution
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Hospitalized patients or Healthy volunteers who entered rooms with the system, and 1)Age 20 and over 2)Patients who had informed concent and written concent form of free will.
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kammei Middle name Last name Rai
Organization	Okayama University Hospital
Division name	Hospital-based Cancer registry division
Zip code	7008558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama, Japan 7008558
TEL	086-235-7227
Email	rai@okayama-u.ac.jp

Public contact
Name of contact person	1st name Kammei Middle name Last name Rai
Organization	Okayama University Hospital
Division name	Hematology Oncology division
Zip code	7008558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama, Japan 7008558
TEL	086-235-7227
Homepage URL
Email	rai@okayama-u.ac.jp

Sponsor
Institute	Hematology Oncology division
Institute
Department

Funding Source
Organization	Okayama University
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	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 city, Okayama, Japan 7008558
Tel	086-235-6938
Email	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	2020 Year 05 Month 27 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	2020 Year 05 Month 27 Day
Date of IRB	2020 Year 07 Month 02 Day
Anticipated trial start date	2020 Year 07 Month 02 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 27 Day
Last modified on	2022 Year 05 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045689