UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049611 |
|---|---|
| Receipt number | R000056128 |
| Scientific Title | Evaluation of task-extraction and acceptability of an artificial intelligence decision model for beginning a cancer risk-judgement service |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2022/11/16 10:51:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of task-extraction and acceptability of an artificial intelligence decision model for beginning a cancer risk-judgement service
Acronym
Evaluation of task-extraction and acceptability of an artificial intelligence decision model for beginning a cancer risk-judgement service
Scientific Title
Evaluation of task-extraction and acceptability of an artificial intelligence decision model for beginning a cancer risk-judgement service
Scientific Title:Acronym
Evaluation of task-extraction and acceptability of an artificial intelligence decision model for beginning a cancer risk-judgement service
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify task-extractions and improvement of a cancer risk-decision artificial intelligence model, and an acceptability of the cancer risk-judgement service, for cancer therapy-completed subjects.
Basic objectives2
Others
Basic objectives -Others
In order to verify task-extractions and improvement of a cancer risk-decision artificial intelligence model, and an acceptability of the cancer risk-judgement service, for cancer therapy-completed subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood-miRNA analysis, blood biochemical tests, hematologic tests, and Brief-type self-administrated Diet History Questionnaire (BDHQ)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects, not less than twenty years old at informed consent.
(2) Subjects being under the conditions described below:
Suffering from colon cancer, and for the duration of their follow-up period (except anticancer drug therapy) or completed their period.
Suffering from other cancers (except colon one), and for the duration of their follow-up period (except anticancer drug therapy).
(3) Subjects who can give informed consent to take part in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects being under some kind of continuous medical treatment (e.g., diabetes mellitus, heart/liver/kidney/mental disease).
(2) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryousuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
General Manager
Zip code
182-0002
Address
Sengawa Kewport 2-5-7 Sengawa-Cho, Chofu, Tokyo 182-0002, Japan
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is conducted to verify task-extractions and improvement of a cancer risk-decision artificial intelligence model, and an acceptability of the cancer risk-judgement service, for cancer therapy-completed subjects.
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
