UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053438 |
|---|---|
| Receipt number | R000059599 |
| Scientific Title | Diagnostic yield Evaluation Studies of a real-time endoscopic Image diaGNosis support system using Artificial Intelligence technology |
| Date of disclosure of the study information | 2024/10/28 |
| Last modified on | 2026/02/05 09:20:44 |
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Basic information
Public title
A multicenter randomized controlled study to evaluate efficacy of a real-time endoscopic diagnosis support system using artificial intelligence technology for the detection of colorectal precancerous lesions and early colorectal cancer
Acronym
DESIGN AI-05 Study
Scientific Title
Diagnostic yield Evaluation Studies of a real-time endoscopic Image diaGNosis support system using Artificial Intelligence technology
Scientific Title:Acronym
DESIGN AI-05 Study
Region
| Japan |
Condition
Condition
Colorectal precancerous lesions and colorectal cancer (confirmed and suspected)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic performance to detect colorectal precancerous lesions and colorectal cancer automatically during colonoscopy using WISE VISION, endoscopic image artificial intelligence diagnosis support system, (hereinafter referred to as endoscopic AI diagnosis support system) in a multicenter setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
PDR (Polyp Detection Rate)
Key secondary outcomes
1) ADR (Adenoma Detection Rate)
2) APPC (Adenomas Per Positive Colonoscopy: number of adenomas detected per positive test)
3) Total examination time
4) Endoscopy insertion time
5) Observation time
6) SSL (Sessile Serrated Lesion) detection rate in whole colon and right colon
7) FDR (Flat adenoma detection rate): Flat adenoma includes macroscopic type IIa, IIb, and IIc
8) DDR (Depressed lesion Detection Rate): Depressed lesion includes macroscopic type IIc alone
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Normal monitor (no AI group)
Interventions/Control_2
Normal monitor + AI monitor (group with 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The physician in charge of the examination has a cumulative experience of 500 cases or more
2) Patients undergoing colonoscopy
3) Age: 20 years old or older and 90 years old or younger (age at the time of registration)
4) ECOG performance status score: 0-2
5) Purpose of examination:
･Examination after positive fecal occult blood results
･Surveillance after polypectomy
･Surveillance after colorectal cancer surgery
･Screening
6) Restrictions on concomitant drugs/concomitant therapy:
･Patients who can discontinue anticoagulant/antiplatelet agents according to the clinical practice guidelines for gastrointestinal endoscopy
7)Written informed consent has been obtained from the patient to participate in the study
Key exclusion criteria
1) Restrictions on medical history and comorbidities:
･Patients who are currently undergoing chemotherapy or radiotherapy for colorectal cancer
･Patients with familial adenomatous polyposis
･Patients with comorbidities (such as chronic hematological disorders) that make lesion resection difficult
･Patients with active inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Hospital
Division name
Division of Endoscopy
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Yamada |
Organization
National Cancer Center Hospital
Division name
Division of Endoscopy
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
TEL
03-3542-2511
Homepage URL
masyamad@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
NEC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）
National Cancer Center Hospital（Tokyo）
東京慈恵会医科大学附属病院（東京都）
Jikei University Hospital（Tokyo）
東京医科大学病院（東京都）
Tokyo Medical University Hospital（Tokyo）
昭和大学医学部内科学講座（東京都）
Department of Medicine, Showa University School of Medicine（Tokyo）
群馬大学医学部附属病院（群馬県）
Gunma University Hospital (Gunma Prefecture)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 28 | 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
752
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
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059599
