UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046502 |
|---|---|
| Receipt number | R000052656 |
| Scientific Title | Examination of detection ability of colorectal polyps with AI colonoscopy |
| Date of disclosure of the study information | 2022/01/04 |
| Last modified on | 2023/01/10 09:29:33 |
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Basic information
Public title
Examination of detection ability of colorectal polyps with AI colonoscopy
Acronym
CAD-COP trial
Scientific Title
Examination of detection ability of colorectal polyps with AI colonoscopy
Scientific Title:Acronym
CAD-COP trial
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the ability to detect colorectal polyps associated with AI colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Examination of AMR (adenoma miss rate)
Key secondary outcomes
1. Examination of PMR (polyp miss rate)
2. Examination of ADR and PDR in First endoscopy
3. Examination of years of experience
4. Examination in inspection time
5. Examination of pathological findings and diagnostic ability of CADx in colorectal polyps
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The CADe group performs routine examination using CADe. Immediately after the examination, the doctor who performed the examination is changed to a doctor with the same number of years of experience in endoscopy skills, and a routine examination without CADe is performed.
Interventions/Control_2
The non-CADe group performs routine examination without CADe. Immediately after the examination, the doctor who performed the examination is changed to a doctor with the same number of years of experience in endoscopy skills, and a routine examination using CADe is performed.
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases scheduled to undergo routine colonoscopy
Cases over 20 years old at the time of diagnosis
Cases in which consent was obtained after receiving sufficient explanation
Key exclusion criteria
Cases with a history of colectomy
Cases that cannot be sufficiently observed due to poor bowel preparation
Cases of inflammatory bowel disease, familial adenomatous polyposis, and other polyposis
Cases with difficult deep insertion
Case of gastrointestinal bleeding for the purpose of endoscopic hemostasis
In addition, cases that it is not suitable for a safe examination method
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisabe |
| Middle name | |
| Last name | Takashi |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin Chikushino-city Fukuoka, Japan
TEL
092-921-1011
hisabe@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ohtsu |
| Middle name | |
| Last name | Kensei |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin Chikushino-city Fukuoka, Japan
TEL
092-921-1011
Homepage URL
k.ohtsu0120@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Department of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma,Jonan-ku,Fukuoka 814-0180
Tel
092-801-1011
fumed-ethics@fukuoka-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
福岡大学筑紫病消化器内科
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 04 | 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
102
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 | 26 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052656
