UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000044748
受付番号 R000051108
科学的試験名 Artificial Intelligence in Colonoscopy for Cancer Prevention -a Randomized Health Service Implementation Project-
一般公開日(本登録希望日) 2021/07/03
最終更新日 2022/10/18 19:43:18

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

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/Condition

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/Objectives

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



評価/Assessment

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.


基本事項/Base

試験の種類/Study type

介入/Interventional


試験デザイン/Study design

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



介入/Intervention

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


適格性/Eligibility

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/Research contact person

責任研究者/Name of lead principal investigator

日本語
PIs: Yuichi Mori and Michael Bretthauer
ミドルネーム
PIs: Yuichi Mori and Michael Bretthauer


英語
PIs: Yuichi Mori and Michael Bretthauer
ミドルネーム
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/Public contact

試験問い合わせ窓口担当者/Name of contact person

日本語
Yuichi
ミドルネーム
Mori


英語
Yuichi
ミドルネーム
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


実施責任個人または組織/Sponsor or person

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


研究費提供組織/Funding Source

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


その他の関連組織/Other related organizations

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


IRB等連絡先(公開)/IRB Contact (For public release)

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

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/Institutions

試験実施施設名称/Institutions



その他の管理情報/Other administrative information

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

2021 07 03


関連情報/Related information

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/Result

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/Progress

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 04 19

倫理委員会による承認日/Date of IRB

2021 06 25

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

2021 07 03

フォロー終了(予定)日/Last follow-up date

2036 12 31

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/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2021 07 03

最終更新日/Last modified on

2022 10 18



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/ctr/ctr_view.cgi?recptno=R000051108


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


研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名