UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042736
Receipt number R000048168
Scientific Title Clinical use of bed sensor system with road cells.
Date of disclosure of the study information 2020/12/13
Last modified on 2023/10/17 11:22:13

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Basic information

Public title

Bed sensor vital-sign monitoring system -comparison between cancer patients under chemotherapy and palliative care.

Acronym

Bed sensor vital-sign monitoring system: clinical usage

Scientific Title

Clinical use of bed sensor system with road cells.

Scientific Title:Acronym

Clinical use of bed sensor system with road cells.

Region

Japan


Condition

Condition

Cancer patients

Classification by specialty

Hematology and clinical oncology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of bed sensor system

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Activity scale and physical status

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cancer patients

Key exclusion criteria

none

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shiroh
Middle name
Last name Isono

Organization

Chiba University Graduate School of medicine

Division name

Department of Anesthesiology

Zip code

260-8670

Address

1-8-1 Inohana Chuo Chiba

TEL

043-226-2155

Email

shirohisono@yahoo.co.jp


Public contact

Name of contact person

1st name Natsuko
Middle name
Last name Nozaki-Taguhi

Organization

Chiba University, graduate school of medicine

Division name

Anesthesiology

Zip code

260-8670

Address

1-8-1 Inohana Chuo Chiba

TEL

043-226-2155

Homepage URL


Email

nnoztag@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Chiba University School of Medicine

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

Chiba University IRB

Address

1-8-1 Inohana Chuo Chiba

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.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 12 Month 13 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

Completed

Date of protocol fixation

2016 Year 11 Month 22 Day

Date of IRB

2016 Year 11 Month 22 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2022 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Research on total weight, heart rate, respiration, activity, and sleep in cancer patient on chemotherapy to palliative care.


Management information

Registered date

2020 Year 12 Month 13 Day

Last modified on

2023 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name