UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044362 |
|---|---|
| Receipt number | R000050671 |
| Scientific Title | Prospective Evaluation of a Computer-aided diagnosis for Narrow-Band Imaging of Colorectal Lesions |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2022/11/28 09:43:55 |
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Basic information
Public title
Clinical Evaluation of Diagnostic Support Software for Colonoscopy
Acronym
Evaluation of AI for colonoscopy
Scientific Title
Prospective Evaluation of a Computer-aided diagnosis for Narrow-Band Imaging of Colorectal Lesions
Scientific Title:Acronym
NBI-CAD study
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of AI for NBI images (NBI-CAD) for colorectal lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To demonstrate that the lower limit of the confidence interval for the sensitivity of NBI-CAD to diminutive colorectal neoplasms exceeds 90%.
Key secondary outcomes
(1) Specificity, NPV, PPV,accuracy of NBI-CAD for diminutive neoplasms.
(2) Sensitivity, specificity, NPV, PPV, and accuracy of NBI-CAD for tumors larger than 5 mm, SSA/P, and hyperplastic polyps.
(3) Sensitivity, specificity, NPV, PPV, accuracy of NBI-CAD for neoplasms when the diagnostic result of NBI-CAD is high confidence (probability >90%).
(4)The sensitivity, specificity, PPV, NPV, and accuracy of NBI-CAD for neoplastic lesions at high confidence (probability > 90%).
(5) Adenoma detection rate
(6) Advanced adenoma / neoplasia detection rate
(7) Time from cecal arrival to endoscope witdrawal
(8) Presence and type of adverse events
(9) Surveillance interval concordance rate
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who do not have any previous information regarding colorectal polyp and will undergo colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital during the period from the approval by the IRB to December 31, 2021.
2) Patients who are 40 years old or older at the time of examination
Key exclusion criteria
(1) Patients with polyposis, such as familial adenomatous polyposis.
(2) Patients with inflammatory bowel disease
(3) Patients who have expressed their refusal for the use of the information
(4) Patients whose pathological diagnosis has been made previously, such as biopsy at a previous doctor's office
(5) Patients who are taking antiplatelet agents or anticoagulants and for whom resection of the lesion is inappropriate.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
Chigasaki-chuo 35-1, Tsuduki, Yokohama
TEL
045-949-7000
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
Chigasaki-chuo 35-1, Tsuduki, Yokohama
TEL
045-949-7000
Homepage URL
mmisawa@med.showa-u.ac.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
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
Address
Chigasaki-chuo 35-1, Tsuduki, Yokohama
Tel
045-949-7000
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 25 | 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
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will undergo endoscopy using conventional endoscopy procedures. When the endoscopist finds a lesion, endoscopist uses WLI, NBI,and chromoendoscopy observation to diagnose the lesion. A still image is taken during NBI observation then the image is analyzed by the AI and output pathological prediction (adenoma, hyperplastic, and SSL) with percentage. It is recommended that the endoscopists take a minimum of five still images from a single lesion. The results will be stored and recorded by the endoscopits/medical stuff. Based on the endoscopist's diagnosis, the lesion will be resected on the same day or at a later date, and a pathological diagnosis will be made. If the results of the pathological diagnosis are inconsistent with the results of the endoscopic diagnosis made by the physician with a high degree of confidence, the physician should consult with the pathologist and consider re-cutting the pathological specimen. The outcomes will be calculated by comparing AI diagnosis and pathological diagnosis.
After the examination, the physician will record the location, lesion diameter, morphology, endoscopic diagnosis, and AI results of the discovered lesion using our endoscopic filing system (Solemio Quev).
Physicians participating in the study will be given a lecture on the use of NBI-CAD, and will be included in the study after performing at least five examinations using the system.
Patients enrollment will be finished if the number of resected diminutive adenoma reached 241.
Management information
Registered date
| 2021 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050671
