UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047666 |
|---|---|
| Receipt number | R000054349 |
| Scientific Title | Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2023/04/22 13:20:12 |
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Basic information
Public title
Veridation research of colonoscopy using artificial intelligence
Acronym
Veridation research of colonoscopy using artificial intelligence
Scientific Title
Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence
Scientific Title:Acronym
Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence
Region
| Japan |
Condition
Condition
colo-rectal adenoma or cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of adenoma detection rate by colonoscopy using artificial intelligence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adenoma detection rate in total colonoscopy
Key secondary outcomes
Adenoma miss rate in recto-sigmoid scopy
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
colonoscopy with/without AI (computer-aided detection)
Interventions/Control_2
colonoscopy without AI (computer-aided detection)
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
| 21 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer screening endoscopy, colonoscopy after fecal occult blood positive test, surveillance after colorectal polyp resection
Key exclusion criteria
After colorectal surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nakashima |
Organization
Foundation for detection of early gastric carcinoma
Division name
depatment of gastroenterology
Zip code
103-0025
Address
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo
TEL
03-3668-6803
nakashima@soiken.or.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nakashima |
Organization
Foundation for detection of early gastric carcinoma
Division name
depatment of gastroenterology
Zip code
103-0025
Address
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo
TEL
03-3668-6803
Homepage URL
nakashima@soiken.or.jp
Sponsor or person
Institute
Foundation for detection of early gastric carcinoma
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM 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
Foundation for detection of early gastric carcinoma
Address
2-6-12, Nihombashikayabacho, Chuo Ward,Tokyo
Tel
03-3668-6803
nakashima@soiken.or.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
https://doi.org/10.1159/000528085
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1159/000528085
Number of participants that the trial has enrolled
415
Results
The ADR was 59.4% in the CADe group and 47.6% in the control group (p = 0.018). The AMRrs was 11.9% in the CADe group and 26.0% in the control group (p = 0.037). The colonoscopy with the CADe system yielded an 11.8% higher ADR than that performed by experienced endoscopists alone. Moreover, there was no need to extend the examination time or request the assistance of additional medical staff to achieve this improved effectiveness.
Results date posted
| 2023 | Year | 01 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 04 | Day |
Baseline Characteristics
We enrolled 415 subjects who under went colonoscopy at our institution from January 2021 to March 2022. The basic demographic and procedural characteristics of the CADe and control groups were as follows: mean age, 54.9 and 55.9 years; male sex, 73.9% and 69.7% of participants; and mean withdrawal time, 411.8 and 399.0 s, respectively.
Participant flow
We enrolled 415 subjects who under went colonoscopy at our institution from January 2021 to March 2022. The eligibility criteria were as follows: (1) aged from 21 to 81 years old on the date of colonoscopy;(2) patients undergoing endoscopy as a primary endoscopic screening for CRC; (3) patients who tested positive for the fecal immunochemical test (FIT) for occult blood; (4) patients with colorectal neoplasia undergoing endoscopic resection; and (5) willingness to participate in the RCT. In contrast, the exclusion criteria included patients who (1) underwent colorectal surgery and (2) had an inflammatory bowel disease. The randomization method used in this study was the numbered container method according to the CONSORT guideline. The allocation message was generated by the computer program of the Python random module and then sealed in sequentially numbered identical containers according to the allocation sequence. After an eligibility check, the endoscopist opened theallocation message, and subsequently, examinees were randomly assigned to the CADe or control groups.
Adverse events
None
Outcome measures
The ADR was 59.4% in the CADe group and 47.6% in the control group (p = 0.018). The AMRrs was 11.9% in the CADe group and 26.0% in the control group (p = 0.037).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054349
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