UMIN-CTR Clinical Trial

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
Email	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
Email	akiko.chino@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050971