UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036839
Receipt number R000041969
Scientific Title Development of diagnostic engine using natural language extracted from medical records
Date of disclosure of the study information 2021/03/31
Last modified on 2019/05/24 11:55:36

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Basic information

Public title

Development of diagnostic engine using natural language extracted from medical records

Acronym

Development of diagnostic engine using natural language extracted from medical records

Scientific Title

Development of diagnostic engine using natural language extracted from medical records

Scientific Title:Acronym

Development of diagnostic engine using natural language extracted from medical records

Region

Japan


Condition

Condition

General Medicine

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Construction of structured database and invention of diagnostic engine

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

F Measure

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

First visit patient to general medicine department

Key exclusion criteria

Person who did not get consent

Target sample size

20000


Research contact person

Name of lead principal investigator

1st name Daiki
Middle name
Last name Yokokawa

Organization

Chiba University Hospital

Division name

Department of General Medicine

Zip code

260-8677

Address

Chiba city

TEL

0432227171

Email

dyokokawa6@chiba-u.jp


Public contact

Name of contact person

1st name Daiki
Middle name
Last name Yokokawa

Organization

Chiba University Hospital

Division name

Department of General Medicine

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba city

TEL

0432227171

Homepage URL


Email

dyokokawa6@chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Ricoh IT Solutions Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

1-8-1, Inohana, Chuo-ku, Chiba city

Tel

043-222-7171

Email

dyokokawa6@chiba-u.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

2021 Year 03 Month 31 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

20000

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

No longer recruiting

Date of protocol fixation

2019 Year 01 Month 04 Day

Date of IRB

2019 Year 01 Month 04 Day

Anticipated trial start date

2019 Year 01 Month 31 Day

Last follow-up date

2019 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

After approval of the ethics review board, the medical records of the study subject meeting the selection criteria are taken out from the database. In the extraction, all items corresponding to personal information are deleted and anonymized.
The text data of the anonymized medical record is subjected to morphological analysis by a computer held in the medical department to extract data (Key data) considered to be necessary for diagnostic reasoning. Design a program that uses python to determine which information (Value data) the extracted information is "yes / no", and stores the clinical diagnostic name-Key data-Value data in one database.
This data is used to design and develop a diagnostic engine. Models that can be considered Bayesian networks, decision trees, or models using deep learning (especially, regression neural networks). These models are used to match the clinical diagnostic name finally determined by the doctor, or to measure its accuracy, to improve the engine.


Management information

Registered date

2019 Year 05 Month 24 Day

Last modified on

2019 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name