UMIN-CTR Clinical Trial

Basic information
Public title	The additional effect of AI support system to detect esophageal cancer -exploratory randomized control trial-
Acronym	AIDEC
Scientific Title	The additional effect of AI support system to detect esophageal cancer -exploratory randomized control trial-
Scientific Title:Acronym	AIDEC
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of artificial intelligence for the diagnosis of esophageal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of detection rate of esophageal cancer with AI support system in less experienced endoscopists.
Key secondary outcomes	Improvement of detection rate of esophageal cancer with AI support system in experienced endoscopists. Improvement of detection rate of esophageal cancer with AI support system in both experienced and less experienced endoscopists. Diagnostic accuracy of esophageal cancer. Accuracy of predicting invasion depth of esophageal cancer. Examination time for esophagus. Adverse event rate.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Patients in group A undergo endoscopy with AI support system. Experienced endoscopists or less experienced endoscopists are used for stratification factor.
Interventions/Control_2	Patients in group B undergo ordinary endoscopy. Experienced endoscopists or less experienced endoscopists are used for stratification factor.
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	Primary esophageal or head and neck cancer. Past history of esophageal / head and neck cancer without undergoing endoscopy in past six month. Patients with informed consent on paper.
Key exclusion criteria	Past history of surgery or radiation therapy for esophagus. Severe stenosis in esophagus. Hypersensitivity for iodine. Contraindication for biopsy with anticoaglant therapy. Infectious disease to treat systemically. Pregnancy or lactating. Mental disorder or dementia.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Toshiyuki
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Gastroenterology
Zip code	135-8550
Address	3-8-31 Ariake Koto-ku Tokyo Japan
TEL	03-3520-0111
Email	toshiyuki.yoshio@jfcr.or.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Toshiyuki
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Gastroenterology
Zip code	135-8550
Address	3-8-31 Ariake Koto-ku Tokyo Japan
TEL	03-3520-0111
Homepage URL
Email	toshiyuki.yoshio@jfcr.or.jp

Sponsor
Institute	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	Takeda Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address	3-8-31 Ariake Koto-ku Tokyo Japan
Tel	03-3520-0111
Email	toshiyuki.yoshio@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	がん研有明病院（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 01 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
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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 09 Month 08 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2021 Year 10 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 24 Day
Last modified on	2020 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045528