UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027360 |
|---|---|
| Receipt number | 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 17:08:21 |
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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
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
ktluck1208@yahoo.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031349
