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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027360
Receipt No. R000031349
Scientific Title Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence -regarding diagnostic accuracy and image acquisition rate of colorectal tumor and cancer-
Date of disclosure of the study information 2017/06/01
Last modified on 2017/12/28

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Basic information
Public title Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence -regarding diagnostic accuracy and image acquisition rate of colorectal tumor and cancer-
Acronym Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence
Scientific Title Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence -regarding diagnostic accuracy and image acquisition rate of colorectal tumor and cancer-
Scientific Title:Acronym Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence
Region
Japan

Condition
Condition colorectal tumor and cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In addition to verifying the diagnostic accuracy of tumor and cancer in computer-aided diagnosis (CAD) system for endocytoscopy (EC)(EC-CAD), we conducted a magnifying and ultra magnifying observation using narrow band- imaging system to evaluate an appropriate image acquisition rate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This trial will be triple primary endpoint clinical trial.

1.When EC-CAD was used under methylene blue staining for polyps of 5 mm or less in
diameter in the sigmoid colon from the rectum, it was verified that the result diagnosed with high confidence (probability 90% or more) was NPV 90% or more.

2.When observing a polyp of 5 mm or less in diameter with magnifying narrow band imaging (NBI) and NBI combined endocytoscopy (EC-NBI), verify that the ratio at which trainee can acquire a focused endoscope video for 3 seconds or more at EC-NBI.

3.When EC-CAD is used under methylene blue staining for colon lesions of 20 mm or more in diameter, we verify that the diagnostic ability for invasive cancer is over 90% PPV.
Key secondary outcomes 1.Diagnostic accuracy of diminitive polyps in EC-CAD and diagnostic accuracy at high confidence in sigmoid colon and rectum.
2.Diagnostic accuracy of diminitive polyps in EC-NBI-CAD and diagnostic accuracy at high confidence in sigmoid colon or rectum.
3.Percentage of methylene blue staining or EC-CAD-NBI succesfuly performed for diminitive polyps less than 5 mm.
4.Diagnostic performance of EC-CAD for polyps whose diameters are 6-9mm or 10mm-
5.Discussion on differences between experts and trainees in each secondary outcome from 1 to 3.
6.Percentage of cases experts can acquire images that were in focus using EC-NBI and NBI for more than 3 seconds.
7.Percentage of cases where experts and trainees can acquire one or more EC-NBI and magnifying NBI images.
8.Percentage of cases where experts and trainees can obtain an in-focus image for 3 seconds or more with diminitive polyps of 5 mm or less and other polyps.
9.Percentage by localization of lesions when experts and trainees can acquire an in-focus image for more than 3 seconds.
10.The difference of the longest time that it was possible to maintain the focused state with EC-NBI and magnifying NBI image.
11.Sensitivity, specificity, correct diagnostic rate, PPV, NPV for invasive cancer when expert and trainee use EC - CAD for colon neoplastic lesions of 20 mm or more.
12.Examination of the cause of EC-CAD diagnostic results becoming low confidence or not a good sample when experts and trainees use EC-CAD.
13.Comparison of the difference in time taken by experts and trainees to acquire 10 EC images after acquiring first EC image.
14.Verification of the influence of depth of tumor on diagnostic results using EC-CAD.
15.Comparison of the difference depending on the depth of tumor invasion when evaluating vessel diameter and caliber change
using CAD for EC-NBI.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Case of over 18 years old at the time of endoscopic examination
2.Case in which pathological diagnosis is possible by biopsy, endoscopic or surgical resection for colon lesions.
3.Cases with normal judgment ability and can express intention
Key exclusion criteria 1.In cases where histological evaluation is impossible (biopsy, pathological evaluation of excised specimens not yet performed).
2.Cases in which pretreatment such as anticancer drug therapy, radiotherapy etc is done.
3.The patient made an offer to refuse to use data with opt-out.
4.A case with inflammatory bowel disease.
5.In addition, cases in which clinical researcher or clinical research sharing doctor judged inappropriate as subject of this examination. .
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Mori
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa
TEL 045-949-7000
Email ibusiginjp@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Takeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa
TEL 045-949-7000
Homepage URL
Email ktluck1208@yahoo.co.jp

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 open public recruiting

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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