UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039924 |
|---|---|
| Receipt number | R000045528 |
| Scientific Title | The additional effect of AI support system to detect esophageal cancer -exploratory randomized control trial- |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/10/22 19:35:22 |
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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
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
toshiyuki.yoshio@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045528
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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