UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038333 |
|---|---|
| Receipt number | 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 10:06:22 |
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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 |
| Obstetrics 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
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/
info_oncolo@3h-ct.co.jp
Sponsor or person
Institute
3H Clinical Trial Inc.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
