UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044748 |
|---|---|
| Receipt number | R000051108 |
| Scientific Title | Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project- |
| Date of disclosure of the study information | 2021/07/03 |
| Last modified on | 2023/09/14 18:42:04 |
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Basic information
Public title
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-
Acronym
ACCEPT project
Scientific Title
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-
Scientific Title:Acronym
ACCEPT project
Region
| Japan | Europe |
Condition
Condition
Colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Removal of adenomas during colonoscopy reduces colorectal cancer incidence and mortality. We and others have recently developed artificial intelligence (AI) systems which aim to optimise colonoscopy quality by increasing the adenoma detection rate (ADR). Meta-analyses of randomized trials at dedicated centres suggests that use of AI in colonoscopy increases ADR of from 20% to 30%, but does not significantly increase detection rates of advanced adenomas. These trials, however, enrolled mainly patients with clinical symptoms. Thus, the unsolved key question is whether the reported increase in adenoma detection is reproducible in population-based cancer screening programs and eventually reduces colorectal cancer incidence and mortality.. The ACCEPT project aims at addressing this important knowledge gap.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Short-term primary endpoints
1. Adenoma detection rate (ADR)
2. Advanced adenoma detection rate (A-ADR)
-Long-term primary endpoints
1. Incidence of colorectal cancers after 10-years follow-up
2. Mortality from colorectal cancers after 10-years follow-up
Key secondary outcomes
1. Proportion of endoscopists with ADRs 25% or higher 8
2. Serrated polyp detection rate
3. Mean number of adenomas per colonoscopy
4. Learning effect of using AI during colonoscopy
5. Benefits from the use of AI according to the expertise
6. Comparison of different AI systems
7. Colonoscopy performance (e.g., cecal intubation rate, insertion and withdrawal time).
8. Rate of adverse events during and within 30 days after colonoscopy
9. Incidence of colorectal cancers in 15-year follow-up
10. Mortality from colorectal cancers in 15-year follow-up
11. All-cause mortality in 10-year and 15-year follow-up
12. Mortality due to causes other than colorectal cancer in 10-year and 15-year follow-up
13. Cost-effectiveness of using AI in a cancer screening programme for colorectal cancer.
14. Retrospective analysis of recorded videos for individuals who have cancer or relevant lesions detected after colonoscopy screening.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Real-time use of AI for polyp detection during colonoscopy
Interventions/Control_2
Colonoscopy without use of AI
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
| 50 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible for inclusion are participants in the national cancer screening programmes in Norway, Poland, Spain, Italy, Denmark, and Japan who undergo either primary colonoscopy screening or colonoscopy after a positive faecal immunochemical screening test.
Key exclusion criteria
Exclusion criteria for the screening programmes are applied in the present study (e.g., individuals with previous history of colorectal cancer).
Target sample size
220000
Research contact person
Name of lead principal investigator
| 1st name | PIs: Yuichi Mori and Michael Bretthauer |
| Middle name | |
| Last name | PIs: Yuichi Mori and Michael Bretthauer |
Organization
University of Oslo
Division name
Clinical Effectiveness Research Group
Zip code
0372
Address
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo
TEL
004740894135
ibusiginjp@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Mori |
Organization
University of Oslo
Division name
Clinical Effectiveness Research Group
Zip code
0372
Address
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo
TEL
0047-40894135
Homepage URL
ibusiginjp@gmail.com
Sponsor or person
Institute
University of Oslo
Institute
Department
Personal name
Funding Source
Organization
Health Trust of South East Norway
European Commission
Japan Society of Promotion for Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Norway/EU/Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
REK (the ethics committee of south-east Norway)
Address
Postboks 1130, Blindern, 0318 Oslo
Tel
0047-22845511
rek-sorost@medisin.uio.no
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 | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study protocol is available under request and approval of all the core study members of the ACCEPT project.
Management information
Registered date
| 2021 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051108
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