UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056392 |
|---|---|
| Receipt number | R000064378 |
| Scientific Title | Prospective study on the development of computer-aided diagnostic systems focused on the JNET classifications for colorectal lesions |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/03/16 12:09:44 |
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Basic information
Public title
Prospective study on the development of computer-aided diagnostic systems focused on the JNET classifications for colorectal lesions
Acronym
Prospective study on development of computer-aided diagnostic systems focused on the JNET classifications
Scientific Title
Prospective study on the development of computer-aided diagnostic systems focused on the JNET classifications for colorectal lesions
Scientific Title:Acronym
Prospective study on development of computer-aided diagnostic systems focused on the JNET classifications
Region
| Japan |
Condition
Condition
colorectal neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the effectiveness of the diagnostic performance of computer-aided diagnosis (CADx) system focused on the JNET classifications for colorectal lesions we developed, through a multicenter prospective cohort study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1:
Diagnostic concordance rate between CADx and expert endoscopists
Study 2:
Diagnostic concordance rate with expert endoscopists for both CADx and non-expert endoscopists
Key secondary outcomes
Study 1:
increase in confidence level among expert endoscopists
diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm)
concordance rate with surveillance intervals recommended by japanese guidelines
correlation with histopathological findings
withdrawal time
study 2:
diagnostic concordance rate with expert endoscopists when the real-time ai-assisted colonoscopy device (cadx) and non-expert endoscopists' diagnoses are consistent
increase in confidence level among non-expert endoscopists and diagnostic concordance rate with expert endoscopists for high-confidence lesions
learning curve of non-expert endoscopists
diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm)
concordance rate with surveillance intervals recommended by japanese guidelines
correlation with histopathological findings
withdrawal time
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) Patients with one or more colorectal neoplastic lesions (SSL, TSA, adenoma, cTis, or cT1a lesions) scheduled for endoscopic treatment.
(2) Patients with one or more lesions classified as cT1b or deeper scheduled for surgical treatment.
(3) Patients aged 18 years or older.
Key exclusion criteria
(1) Patients with polyposis symdrome (e.g., familial adenomatous polyposis, Lynch syndrome, or SPS [Serrated Polyposis Syndrome]).
(2) Patients with inflammatory bowel disease.
(3) Patients with coexisting advanced colorectal cancer.
(4) Patients with inadequate bowel preparation, indicated by a BBPS (Boston Bowel Preparation Scale) score of less than 6.
(5) Cases where the principal investigator or sub-investigators deem participation in the study to be inappropriate.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology
Zip code
734-8551
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
TEL
082-257-5190
oka4683@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Kuwai |
Organization
Hiroshima University Hospital, Hiroshima, Japan
Division name
Gastrointestinal Endoscopy and Medicine
Zip code
734-8551
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
TEL
082-257-5193
Homepage URL
kuwai@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self-Procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterology, Hiroshima University Hospital, Hiroshima, Japan
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
Tel
082-257-5190
oka4683@hiroshima-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
| 2025 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064378
