UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061058 |
|---|---|
| Receipt number | R000069863 |
| Scientific Title | A study on the color difference between normal and special light observation during endoscopic procedures for colorectal tumors. |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 19:41:58 |
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Basic information
Public title
A study on the color difference between normal and special light observation during endoscopic procedures for colorectal tumors.
Acronym
Evaluation of ACI (Acute Colorectal Infection Control) Screening for Colorectal Tumors
Scientific Title
A study on the color difference between normal and special light observation during endoscopic procedures for colorectal tumors.
Scientific Title:Acronym
Evaluation of ACI (Acute Colorectal Infection Control) Screening for Colorectal Tumors
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to improve the diagnostic accuracy of superficial colorectal tumors by comparing the color differences between ACI(Amber-Red color Imaging)and WLI(White Light Imaging) during lower gastrointestinal endoscopy for colorectal tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in color is determined by comparing WLI and ACI in each lesion (including indigo carmine spray images).
Key secondary outcomes
- Calculate quantitative evaluation of color difference, and analyze its distribution and correlation with lesion characteristics.
- Correlation between the presence or absence of color difference and tumor characteristics (e.g., histological type, degree of atypia).
- Inter-observer agreement rate regarding color difference determination.
- Frequency of color difference occurrence by lesion characteristic.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include patients who visit the outpatient clinic at Keio University Hospital within approximately two years (March 2028) from the date of authorization from the head of the research institution, are diagnosed with a colorectal tumor, undergo lower gastrointestinal endoscopy using a Fujifilm endoscopic system (ELUXEO 8000 system), and who have given informed consent regarding this study.
Key exclusion criteria
- Cases involving minors or those lacking the capacity to consent due to dementia, etc.
- Other cases deemed unsuitable for registration by the attending physician
- Cases where the research participant refuses to participate in this study after registration.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Ike |
Organization
Keio University
Division name
Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
hitomiike2@gmail.com
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University
Division name
Endoscopy center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
marimizutani6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By comparing the color differences between ACI and WLI, we aim to clarify the potential for improving lesion detection and extent diagnosis, thereby contributing to improved diagnostic rates for superficial colorectal tumors in the future.
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069863
