UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039597 |
|---|---|
| Receipt number | R000045155 |
| Scientific Title | Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/02/25 18:10:08 |
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Basic information
Public title
Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Acronym
Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Scientific Title
Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Scientific Title:Acronym
Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Region
| Japan |
Condition
Condition
upper gastrointestinal cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Collection of endoscopic images of upper gastrointestinal cancers, development of an AI system for detection of upper gastrointestinal cancers, and assessment of an AI system performance by expert endoscopists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An accuracy of an AI system for detection of upper gastrointestinal cancers in endoscopic images
Key secondary outcomes
An accuracy of an AI system for classification of upper gastrointestinal cancers in endoscopic images
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
1)Patients undergoing endoscopy to inspect lesions suspicious for upper gastrointestinal cancers
2)Patients aged 20 years or older at the time of enrollment
3)Patients who have provided written informed consent to participate in this study
Key exclusion criteria
1)Patients after upper gastrointestinal surgery
2)Patients investigator judged unsuitable as the research subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujishiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology & Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
mtfujish@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Hirai |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology & Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
hiraik53@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The IRB of Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
iga-shinsa@adm.nagoya-u.ac.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
| 2020 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Upper gastrointestinal endoscopy will be performed for patients who meet the selection criteria between March 2020 and December 2021.Endoscopic images of lesions suspicious for upper gastrointestinal cancers and data about clinicopathologic characteristics will be collected.
Management information
Registered date
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045155
