UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045456 |
|---|---|
| Receipt number | R000051899 |
| Scientific Title | Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study |
| Date of disclosure of the study information | 2021/09/11 |
| Last modified on | 2023/03/14 12:02:10 |
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Basic information
Public title
Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study
Acronym
CONFIDENTIAL study
Scientific Title
Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study
Scientific Title:Acronym
CONFIDENTIAL study
Region
| Japan |
Condition
Condition
Suspected colorectal tumor (including colorectal adenoma)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify how much colorectal adenoma detection has an additional effect on normal screening examinations using a colonoscopy equipped with AI function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of overall adenoma lesion detection rate (ADR) between endoscopists and Artificial Intelligence
Key secondary outcomes
(1) Comparison of the number of adenomas per case (adenomas / number of cases) between endoscopists and Artificial Intelligence
(2) Comparison of ADR between specialists and non-specialists (including residents)
(3) Comparison of the number of adenomas per case between specialists and non-specialists (including residents)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who undergo colonoscopy without a history of colonoscopy for more than 3 years at the research facility
(2) Patients who can perform preparation as usual
Key exclusion criteria
(1) Emergency endoscopy case
(2) Patients with a history of colectomy or severe adhesions of colon are known in advance
(3) Patients with chronic bowel disease such as inflammatory bowel disease
(4) Patients with poor preparation
(5) Patients judged inappropriate by the doctor in charge of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University, Faculty of medicine
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Mizukami |
Organization
Oita University, Faculty of medicine
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Department of Gatroenterology, Faculty of medicine, Oita University
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
Ethics Committee of Oita University, Faculty of Medicine
Address
1-1, idaigaoka, Hasama, Yufu, Oita
Tel
097-586-6380
rinrikenkyu@oita-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
| 2021 | Year | 09 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051899
