UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-

英語
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-

一般向け試験名略称/Acronym

日本語
ACCEPT project

英語
ACCEPT project

科学的試験名/Scientific Title

日本語
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-

英語
Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-

科学的試験名略称/Scientific Title:Acronym

日本語
ACCEPT project

英語
ACCEPT project

試験実施地域/Region

日本/Japan	欧州/Europe

対象疾患名/Condition

日本語
Colorectal neoplasm

英語
Colorectal neoplasm

疾患区分1/Classification by specialty

消化器内科学（消化管）/Gastroenterology

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
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.

英語
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.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
-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

英語
-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

副次アウトカム評価項目/Key secondary outcomes

日本語
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.

英語
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.

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

試験参加者がブラインド化されている単盲検/Single blind -participants are blinded

コントロール/Control

無治療対照/No treatment

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

2

介入の目的/Purpose of intervention

予防・検診・検査/Prevention

介入の種類/Type of intervention

医療器具・機器/Device,equipment

介入1/Interventions/Control_1

日本語
Real-time use of AI for polyp detection during colonoscopy

英語
Real-time use of AI for polyp detection during colonoscopy

介入2/Interventions/Control_2

日本語
Colonoscopy without use of AI

英語
Colonoscopy without use of AI

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

50

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

74

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
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.

英語
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.

除外基準/Key exclusion criteria

日本語
Exclusion criteria for the screening programmes are applied in the present study (e.g., individuals with previous history of colorectal cancer).

英語
Exclusion criteria for the screening programmes are applied in the present study (e.g., individuals with previous history of colorectal cancer).

目標参加者数/Target sample size

220000

責任研究者/Name of lead principal investigator

日本語

名	PIs: Yuichi Mori and Michael Bretthauer
ミドルネーム
姓	PIs: Yuichi Mori and Michael Bretthauer

英語

名	PIs: Yuichi Mori and Michael Bretthauer
ミドルネーム
姓	PIs: Yuichi Mori and Michael Bretthauer

所属組織/Organization

日本語
University of Oslo

英語
University of Oslo

所属部署/Division name

日本語
Clinical Effectiveness Research Group

英語
Clinical Effectiveness Research Group

郵便番号/Zip code

0372

住所/Address

日本語
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo

英語
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo

電話/TEL

004740894135

Email/Email

ibusiginjp@gmail.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名	Yuichi
ミドルネーム
姓	Mori

英語

名	Yuichi
ミドルネーム
姓	Mori

組織名/Organization

日本語
University of Oslo

英語
University of Oslo

部署名/Division name

日本語
Clinical Effectiveness Research Group

英語
Clinical Effectiveness Research Group

郵便番号/Zip code

0372

住所/Address

日本語
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo

英語
Gaustad Sykehus, Bygg 20, Sognsvannsveien 21, Oslo

電話/TEL

0047-40894135

試験のホームページURL/Homepage URL

Email/Email

ibusiginjp@gmail.com

機関名/Institute

日本語
その他

英語
University of Oslo

機関名/Institute
（機関選択不可の場合）

日本語
University of Oslo

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Health Trust of South East Norway
European Commission
Japan Society of Promotion for Science

機関名/Organization
（機関選択不可の場合）

日本語
Health Trust of South East Norway
European Commission
Japan Society of Promotion for Science

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語
Norway/EU/Japan

英語
Norway/EU/Japan

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
REK (the ethics committee of south-east Norway)

英語
REK (the ethics committee of south-east Norway)

住所/Address

日本語
Postboks 1130, Blindern, 0318 Oslo

英語
Postboks 1130, Blindern, 0318 Oslo

電話/Tel

0047-22845511

Email/Email

rek-sorost@medisin.uio.no

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2021

年

07

月

03

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

一般募集中/Open public recruiting

プロトコル確定日/Date of protocol fixation

2021

年

04

月

19

日

倫理委員会による承認日/Date of IRB

2021

年

06

月

25

日

登録・組入れ開始（予定）日/Anticipated trial start date

2021

年

07

月

03

日

フォロー終了(予定)日/Last follow-up date

2036

年

12

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語
Study protocol is available under request and approval of all the core study members of the ACCEPT project.

登録日時/Registered date

2021

年

07

月

03

日

最終更新日/Last modified on

2023

年

09

月

14

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000051108

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051108