UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044622 |
|---|---|
| Receipt number | R000050971 |
| Scientific Title | A multicenter study for colorectal polyp detection performance of Computer-Aided-Detection (CADe) system for endoscopy |
| Date of disclosure of the study information | 2021/06/22 |
| Last modified on | 2022/07/05 16:14:21 |
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Basic information
Public title
Performance evaluation of Computer-Aided polyp Detection system with artificial intelligence (AI) for colonoscopy
Acronym
Performance evaluation of Computer-Aided polyp Detection system for colonoscopy
Scientific Title
A multicenter study for colorectal polyp detection performance of Computer-Aided-Detection (CADe) system for endoscopy
Scientific Title:Acronym
Performance evaluation of endoscopy CADe system
Region
| Japan |
Condition
Condition
Colorectal lesion type 0 in the classification of gross appearance.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the colorectal lesion detection performance of the CADe system for endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity for detecting the colorectal lesion of the CADe system.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo total colonoscopy at the institutions during the study period.
Key exclusion criteria
Patients who:
- have been diagnosed with inflammatory bowel disease;
- have been diagnosed with polyposis coli;
- do not agree to participate in this study;
- are under the age of 20;
- undergo colonoscopy as treatment;
- underwent total proctocolectomy in the past;
- are participating in other clinical studies or trials that might have direct or indirect effects on results from this study;
- cannot observe instructions of this study and colonoscopy and;
- are judged to be inappropriate as a subject of this study by the principal investigator, for other reasons.
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Igarashi |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Digestive of Gastroenterology
Zip code
135-8550
Address
3-8-31 Ariake,Koto-ku, Tokyo, Japan
TEL
03-3520-0111
masahiro.igarashi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Chino |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Digestive of Gastroenterology
Zip code
135-8550
Address
3-8-31 Ariake,Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
akiko.chino@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
OLYMPUS Medical Systems Corp.
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
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Address
3-8-31 Ariake,Koto-ku, Tokyo, Japan, 135-8550
Tel
03-3520-0111
med.shinsa@jfcr.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
| 2021 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.jddw.jp/jddw2021/abstracts/abst/40590.html
Number of participants that the trial has enrolled
185
Results
In this study, 185 cases were identified for evaluation and 557 lesions were determined by the endoscopists as the gold standard. The results of this study showed that the lesion detection sensitivity of the colonoscopy CADe system was 97.5%.
Results date posted
| 2022 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
male: 122, female: 63
Participant flow
Of the subjects who met the inclusion criteria and not violate the exclusion criteria, 185 subjects with lesions were included in this study and all were analyzed.
Adverse events
N/A
Outcome measures
The sensitivity evaluated as the primary endpoint was 97.5% [95%CI: 95.8-98.5%].
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 21 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 25 | Day |
Other
Other related information
A total of four institutes participating in this joint study including the Cancer Institute Hospital of JFCR performed colonoscopy from December 2019 to August 2020. The performance of the CADe system for endoscopy was evaluated with videos, which were recorded during the colonoscopy after obtaining informed consent from the patients.
Management information
Registered date
| 2021 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050971
