UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041823 |
|---|---|
| Receipt number | R000047273 |
| 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 | 2020/09/25 |
| Last modified on | 2023/03/20 10:30:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Diagnostic yield Evaluation Studies of a real-time endoscopic Image diagNosis support system using Artificial Intelligence technology
Acronym
DESIGN AI-02 Pilot 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-02 Pilot Study
Region
| Japan |
Condition
Condition
Colorectal Neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an artificial intelligence (AI) system that automatically detects early signs of colorectal cancer, as well as to confirm effectiveness during colonoscopy, in multicenter.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Adenoma Detection Rate
Key secondary outcomes
1) Adenoma per Positive Colonoscopy
2) Polyp Detection Rate
3) Total procedure time
4) Insertion time
5) Withdrawal time
6) Acceptance (Questionnaire)
7) Sessile serrated lesion detection rate
8) Flat adenoma Detection Rate
9) Depressed lesion Detection Rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patients who undergo colonoscopy
2) Age: 20 to 90 (at the registry)
3) ECOG performance status: 0-2
4) No prior chemotherapy and radiation therapy for colorectal cancer
5) Patients who can follow Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment
6) Written informed consent
Key exclusion criteria
1) Familial adenomatous polyposis
2) Patients with complications, such as chronical hematological disease
3) Patients with active inflammatory bowel diseases, such as ulcerative colitis or Crohn's disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Yamada |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
masyamad@ncc.go.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Yamada |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@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）
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
110
Results
The overall adenoma detection rate was 49.1% (95% CI: 39.4% to 58.8%), the polyp detection rate was 60.9% (51.1% to 70.1%), the average polyps per colonoscopy was 1.7 (1.33 to 2.10), the false detection rate was 36.4% (27.4% to 46.1%), the detection rate of diminutive polyps was 0% (0% to 3.3%), and the right-sided colon detection rate was 4.5% (1.5% to 10.3%). The median insertion time was 5.6 (ranging from 1.5 to 25) minutes, and the median observation time was 10.4 (ranging from 3.8 to 29.9) minutes.
Results date posted
| 2023 | Year | 03 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male/Female = 61/49, median age of 67 (ranging from 32 to 83) years old. The aim of the colonoscopies were fecal occult blood test, post-polypectomy surveillance, postoperative surveillance, screening, and symptomatic evaluation, with 10, 38, 32, 26, and 4 cases, respectively. Nineteen endoscopists conducted the colonoscopies, with specialists performing 60 cases (55%) and non-specialists performing 50 cases (45%). A total of 71 and 39 cases used endoscopes from companies A and B, respectively.
Participant flow
Not applicable
Adverse events
none
Outcome measures
overall adenoma detection rate (ADR), polyp detection rate (PDR), average polyps per colonoscopy (APPC) , false detection rate (FDR), detection rate of diminutive polyps (DDR), right-sided colon detection rate (SDR), median insertion time, median observation time, Patients' acceptance of AI-assisted examinations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047273
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
