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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name