UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039198 |
|---|---|
| Receipt number | R000044701 |
| Scientific Title | A study on establishment of diagnostic method for oral mucosal disease using artificial intelligence |
| Date of disclosure of the study information | 2020/01/19 |
| Last modified on | 2020/01/19 16:57:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiraoka@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044701
