UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053777 |
|---|---|
| Receipt number | R000061151 |
| Scientific Title | Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy. |
| Date of disclosure of the study information | 2024/03/10 |
| Last modified on | 2024/04/15 12:56:04 |
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Basic information
Public title
Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.
Acronym
Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.
Scientific Title
Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.
Scientific Title:Acronym
Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.
Region
| Japan |
Condition
Condition
Sessile serrated lesion or Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to validate the superiority of SSL detection rate (SSL-DR) by colonoscopy with LCI and artificial intelligence over colonoscopy with LCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The primary outcome is the SSL detection rate, defined as the proportion of participants with at least one SSL.
Key secondary outcomes
1. The adenoma detection rate (ADR), defined as the proportion of participants with at least one polyp at a per-patient analysis.
2. The polyp detection rate (PDR), defined as the proportion of participants with at least one polyp at a per-patient analysis.
3. The advanced ADR, defined as the proportion of participants with at least one advanced adenoma at a per-patient analysis.
4. The TSA-DR, defined as the proportion of participants with at least one TSA at a per-patient analysis.
5. The proximal ADR, defined as the proportion of participants with at least one adenoma at the proximal colon (cecum to transverse colon) at a per-patient analysis.
6. The mean number of adenomas per patient.
7. The mean number of polyps per patient.
8. The mean number of advanced adenomas per patient.
9. The mean number of SSLs per patient.
10. The mean number of TSAs per patient.
11. The adenoma or polyp detection rate according to clinicopathological characteristics of the lesions.
16. Observation time.
17. Adverse event rates.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Whole colonic mucosa is observed by the linked color imaging (LCI).
Interventions/Control_2
Whole colon mucosa is observed by a combination of linked color imaging (LCI) and computer-aided detection.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who will undergo colonoscopy
2. Age of 40-89 years
3. Performance status (ECOG) 0, 1, or 2
4. Written informed consent
Key exclusion criteria
1. Whole colonoscopy not scheduled
2. History of colorectal surgery (The only appendectomy is acceptable)
3. Known colorectal adenoma, polyp, or cancer before the trial
4. Known inflammatory bowel disease
5. Known hereditary or non- hereditary polyposis syndrome
6. Difficulty in completing observation of the mucosa of the whole colon
7. Difficult to collect pathology tissue
8. Already participating in this study
9. Others
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Ikehara |
Organization
Kitasato university
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8111
h.ikehara@gmail.com
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Horii |
Organization
Kitasato university
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8111
Homepage URL
horiitoshiki@gmail.com
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Kitasato university
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
Institutional Review Board of Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
+81117221110
rinrib@med.kitasato-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
国際医療福祉大学市川病院(千葉県)、聖マリアンナ医科大学病院（神奈川県）、京都府立医科大学附属病院（京都府）、佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
| 2024 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061151
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