UMIN-CTR Clinical Trial

Basic information
Public title	A study on establishment of diagnostic method for oral mucosal disease using artificial intelligence
Acronym	A study for diagnosis of oral mucosal disease
Scientific Title	A study on establishment of diagnostic method for oral mucosal disease using artificial intelligence
Scientific Title:Acronym	A study for diagnosis of oral mucosal disease
Region	Japan

Condition
Condition	Oral mucosal disease
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Develop a diagnostic support system for oral mucosal disease using artificial intelligence and verify its accuracy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of oral mucosal disease
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 have objective data such as photographs and pathology regarding the presence or absence of oral mucosal disease
Key exclusion criteria	Other than those above
Target sample size	8000

Research contact person
Name of lead principal investigator	1st name Shin-ichiro Middle name Last name Hiraoka
Organization	Osaka University Dental Hospital
Division name	Department of Oral and Maxillofacial Surgery 1
Zip code	565-0871
Address	Suita
TEL	+81-6-6879-5111
Email	hiraoka@dent.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shin-ichiro Middle name Last name Hiraoka
Organization	Osaka University Dental Hospital
Division name	Department of Oral and Maxillofacial Surgery 1
Zip code	565-0871
Address	Suita
TEL	909730628
Homepage URL
Email	hiraoka@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University Dental Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, School & Graduate School of Dentistry, Osaka University
Address	1-8 Yamadaoka, Suita, Osaka, 565-0871 Japan
Tel	+81-6-6879-5111
Email	hiraoka@dent.osaka-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 01 Month 19 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 01 Month 09 Day
Date of IRB	2019 Year 01 Month 16 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2020 Year 01 Month 19 Day
Last modified on	2020 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044701