UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031349
Receipt number R000035787
Scientific Title Construction of the novel computer-aided diagnosis system for predicting histological healing of UC patients using endocytoscopy
Date of disclosure of the study information 2018/02/17
Last modified on 2018/02/17 16:17:15

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Basic information

Public title

Construction of the novel computer-aided diagnosis system for predicting histological healing of UC patients using endocytoscopy

Acronym

Construction of the novel computer-aided diagnosis system for histological healing using endocytoscopy

Scientific Title

Construction of the novel computer-aided diagnosis system for predicting histological healing of UC patients using endocytoscopy

Scientific Title:Acronym

Construction of the novel computer-aided diagnosis system for histological healing using endocytoscopy

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to develop and evaluate a computer-aided diagnosis system for histological healing of UC.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for histological healing in patient-based analysis.

Key secondary outcomes

Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for histological healing in segment-based analysis.


Base

Study type

Others,meta-analysis etc


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

15 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

UC patients who were taken biopsy after observation with endocytoscopy

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuharu Maeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan

TEL

0459497567

Email

yasuharumaeda610@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yasuharu Maeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan

TEL

0459497567

Homepage URL


Email

yasuharumaeda610@hotmail.com


Sponsor or person

Institute

Digestive Disease Center, Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

Grants in Aid for Scientific Research from the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 02 Month 17 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

Completed

Date of protocol fixation

2018 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

endoscopic images are allocated to an automated diagnosis sysetm and endoscopists for assessment of accuracy of pathological prediction.
Diganostic accuracies, and confidence levels are evaluated.


Management information

Registered date

2018 Year 02 Month 17 Day

Last modified on

2018 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name