UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035330
Receipt number R000040251
Scientific Title Objective evaluation of cancer pain using non-contact sensor
Date of disclosure of the study information 2018/12/20
Last modified on 2023/06/28 13:51:23

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Basic information

Public title

Objective evaluation of cancer pain using non-contact sensor

Acronym

Objective evaluation of cancer pain using non-contact sensor

Scientific Title

Objective evaluation of cancer pain using non-contact sensor

Scientific Title:Acronym

Objective evaluation of cancer pain using non-contact sensor

Region

Japan


Condition

Condition

Cancer
Healthy individuals

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the possibility of objective rating of cancer pain using a non-contact sensing system.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quantification of cancer pain

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

Patients with cancer pain and healthy individuals

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

Cancer patients
Patients who have confirmed cancer diagnosis and are notified
Patients with persistent or intermittent pain thought to be due to cancer

Healthy individuals
Individuals without pain
Individuals without chronic diseases

Key exclusion criteria

Cancer patients
Patients with other strong symptoms other than cancer pain
Patients who are expected to develop rapid medical condition
Patients with visual acuity / hearing impairment
Patients with skin disease on the face

Healthy individuals
Individuals with visual acuity / hearing impairment
Individuals with skin disease on the face

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Yamasaki

Organization

Tottori University Faculty of Medicine

Division name

Division of Medical Oncology and Molecular Respirology

Zip code

683-8504

Address

36-1 Nishi-cho, Yonago, Tottori

TEL

0859-38-6537

Email

yamasaki@tottori-u.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Yamaguchi

Organization

Tottori University Faculty of Medicine

Division name

Division of Medical Oncology and Molecular Respirology

Zip code

683-8504

Address

36-1 Nishi-cho, Yonago, Tottori

TEL

0859-38-6537

Homepage URL


Email

kske2@tottori-u.ac.jp


Sponsor or person

Institute

Tottori University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tottori University Faculty 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

Tottori University Faculty of Medicine

Address

36-1 Nishi-cho, Yonago, Tottori

Tel

0859-38-7014

Email

me-rinshoukenkyu@ml.adm.tottori-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

2018 Year 12 Month 20 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

Open public recruiting

Date of protocol fixation

2016 Year 11 Month 01 Day

Date of IRB

2016 Year 10 Month 13 Day

Anticipated trial start date

2016 Year 11 Month 01 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



Management information

Registered date

2018 Year 12 Month 20 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040251


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name