UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013917 |
|---|---|
| Receipt number | R000016229 |
| Scientific Title | Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions. |
| Date of disclosure of the study information | 2014/05/10 |
| Last modified on | 2022/11/14 18:49:00 |
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Basic information
Public title
Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Acronym
Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Scientific Title
Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Scientific Title:Acronym
Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Region
| Japan |
Condition
Condition
Small colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the usefulness of endocytoscopy-based computer-aided diagnosis system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic abilities for detecting neoplastic change of small polyps;sensitivity, specificity, accuracy, positive predictive value, and negative predictive value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Diagnosis by endoscopists
Interventions/Control_2
Diagnosis with use of the endocytoscopy-based computer-aided diagnosis system
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
Patients who undergo colonoscopy and detected of a small polyp (=<10mm) whose histology is unknown.
Key exclusion criteria
Inflamatory bowel disease
Patients from whom clear endoscopic images are difficult to obtain
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL
045-949-7693
ibusiginjp@hotmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Mori |
Organization
Showa University Northen Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL
045-949-7693
Homepage URL
ibusiginjp@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, 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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo
Tel
+81459497000
irb02syh@ofc.showa-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
昭和大学横浜市北部病院消化器センター（神奈川県）
Digestive Disease Center, Showa University Northern Yokohama Hospital (Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016229
