UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051237 |
|---|---|
| Receipt number | R000056964 |
| Scientific Title | Comparison of the ability of Artifical intelligence-based computer-aided detection (CAD) systems and endoscopists to detect colorectal neoplastic lesions. |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/12/02 09:15:50 |
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Basic information
Public title
Comparison of the ability of artifical intelligence-based computer-aided detection (CAD) systems and endoscopists to detect colorectal neoplastic lesions.
Acronym
Comparison of the ability of CAD systems and endoscopists to detect colorectal neoplastic lesions.
Scientific Title
Comparison of the ability of Artifical intelligence-based computer-aided detection (CAD) systems and endoscopists to detect colorectal neoplastic lesions.
Scientific Title:Acronym
Comparison of the ability of CAD systems and endoscopists to detect colorectal neoplastic lesions.
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the superiority of CAD and endoscopists' ability to detect colorectal neoplastic lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superiority of time taken by the endoscopist to detect colorectal neoplastic polyps versus by the CAD to detect colorectal neoplastic polyps (number of wins/losses)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases of colonoscopy performed from June 1st 2022 to July 31th 2022 by the study coordinator at Tokyo Women's Medical University hospital in which two types of videos were recorded simultaneously, one using the CAD function and the other not using it.
Endoscopists who view the videos will be selected from endoscopists who work in the Institute of Gastroenterology, or the Department of Digestive Endoscopy at Tokyo Women's Medical University Hospital and who perform colonoscopies on a daily basis. 3 experts who have performed more than 5000 colonoscopies and 3 beginners who have performed less than 500 colonoscopies will be selected.
Key exclusion criteria
Cases with poor preparation
Cases in which CAD indicated more than 5 colorectal polyps of 10 mm or less
Cases in which endoscopic procedures were performed including biopsy
Cases in which no neoplastic lesions were detected
Inflammatory bowel disease and polyposis
Cases with an examination time of 20 minutes or longer
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Misumi |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Digestive Endoscopy
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan.
TEL
+81333538111
yoshikft34@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Misumi |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Digestive Endoscopy
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan.
TEL
+81333538111
Homepage URL
yoshikft34@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Hospital
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan.
Tel
+81333538111
yoshikft34@gmail.com
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
| 2023 | Year | 06 | Month | 02 | 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
47
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
This study involves a single center, Tokyo Women's Medical University Hospital. Endoscopy videos are used to evaluate whether CAD EYE, an AI equipped colonoscope CAD system, is superior to endoscopists in its ability to detect colorectal neoplastic lesions, and to compare the times needed by CAD EYE and the endoscopists to detect tumors. This study approved by the ethics committee of Tokyo Women's Medical University. Informed consent was obtained from all patients for using the videos. Patients are free to withdraw consent at any time. In addition to the study coordinator, Endoscopist A, a total of six people participated in this study, three experts (>5000 colonoscopies) and three beginners (<500 colonoscopies).
Study population
The study will use colonoscopies performed by Endoscopist A at Tokyo Women's Medical University Hospital from June 1 to July 30, 2022, using a high- definition colonoscope and a high-definition monitor. We do not examine the symptoms, purpose of examination, age, or sex of any of the patients. The inclusion criteria are the presence of at least one neoplastic lesion (adenoma or adenocarcinoma) measuring<10mm. For the final determination of whether the lesion is neoplastic, the gold standard is CAD EYE's CADx diagnosis. Patients with poor pretreatment, with >5 neoplastic lesions, with inflammatory bowel disease, with polyposis, who underwent endoscopic procedures that include biopsies, and whose examination took>20 min will be excluded.
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056964
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