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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038333
Receipt No. R000043686
Scientific Title Siteless Virtual Study for Validation of Adverse Events Monitoring Application in Oncology
Date of disclosure of the study information 2019/10/18
Last modified on 2020/04/17

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Basic information
Public title Siteless Virtual Study for Validation of Adverse Events Monitoring Application in Oncology
Acronym ONCOLO Virtual Trial
Scientific Title Siteless Virtual Study for Validation of Adverse Events Monitoring Application in Oncology
Scientific Title:Acronym ONCOLO Virtual Trial
Region
Japan

Condition
Condition cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Neurology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Urology
Radiology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To validate of adverse events monitoring application
2. To research the change of QOL (Week0 to Week4)
3. To collect date by wearable device
Basic objectives2 Others
Basic objectives -Others System validation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. System error rate (Week0 to Week4)
2. Input rate (Week0 to Week4)
3. QOL change rate (Week0 to Week4)
4. The date collected by wearable device (Week0 to Week4)
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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. The subject is signing informed consent.
2. The subject can prove that they have had cancer.
3. The subject can understand Japanese.
Key exclusion criteria The subject suspected of cognitive decline or psychiatric disorder that may be difficult to meet the requirements of this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenta
Middle name
Last name Kachi
Organization 3H Clinical Trial Inc.
Division name LIFTA for Oncology
Zip code 171-0022
Address Ikebukuro YS Building 2F, 1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan 171-0022
TEL 03-5985-0053
Email info_oncolo@3h-ct.co.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Nakayama
Organization 3H Clinical Trial Inc.
Division name LIFTA for Oncology
Zip code 171-0022
Address Ikebukuro YS Building 2F, 1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan 171-0022
TEL 03-5985-0053
Homepage URL https://oncolo.jp/ct/oncolovirtualtrial/
Email info_oncolo@3h-ct.co.jp

Sponsor
Institute 3H Clinical Trial Inc.
Institute
Department

Funding Source
Organization 3H Clinical Trial Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Japan Conference of Clinical Research
Address Ikebukuro YS Building 8F, 1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan 171-0022
Tel 03-6868-7022
Email jccr-info@jccr.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 10 Month 18 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
2019 Year 10 Month 03 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 10 Month 18 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
2020 Year 02 Month 28 Day
Date trial data considered complete
2020 Year 03 Month 15 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information ONCOLO homepage
https://oncolo.jp/

ONCOLO Virtual Trial
https://oncolo.jp/ct/oncolovirtualtrial/

Management information
Registered date
2019 Year 10 Month 18 Day
Last modified on
2020 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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