UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059820 |
|---|---|
| Receipt number | R000068237 |
| Scientific Title | Diagnostic performance of endoscopic features for sessile serrated lesions: comparison between the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (3rd English Edition) and the WHO 5th edition histopathological criteria |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/19 07:44:50 |
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Basic information
Public title
Diagnostic performance of endoscopic features for sessile serrated lesions: comparison between the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (3rd English Edition) and the WHO 5th edition histopathological criteria
Acronym
Endoscopic diagnosis of SSLs under Japanese and WHO criteria
Scientific Title
Diagnostic performance of endoscopic features for sessile serrated lesions: comparison between the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (3rd English Edition) and the WHO 5th edition histopathological criteria
Scientific Title:Acronym
Endoscopic diagnosis of SSLs under Japanese and WHO criteria
Region
| Japan |
Condition
Condition
sessile serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Two histopathological classifications, JSCCR and WHO 2019, are currently used for diagnosing serrated lesions in Japan. This study aimed to compare endoscopic diagnostic performance based on each criterion and to clarify features of discordant lesions (WHO-SSL but JSCCR-HP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of SSL detection using endoscopic scores (AUC: Area Under the ROC Curve)
Comparison of AUC values between the Japanese Classification and the WHO 5th edition criteria
Key secondary outcomes
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
Lesions that were endoscopically resected and histopathologically diagnosed as serrated lesions, including hyperplastic polyp (HP), sessile serrated adenoma/polyp (SSA/P), sessile serrated lesion (SSL), or microvesicular hyperplastic polyp (MVHP).
Only specimens that were adequately preserved and suitable for histopathological evaluation were included.
Key exclusion criteria
Traditional serrated adenoma (TSA)
Poorly preserved or inadequate specimens
Serrated polyposis syndrome (SPS)
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | KOICHI |
| Middle name | |
| Last name | HAMADA |
Organization
Southern-Tohoku General Hospital
Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
9638563
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima
TEL
0249345322
ag14072@yahoo.co.jp
Public contact
Name of contact person
| 1st name | KOICHI |
| Middle name | |
| Last name | HAMADA |
Organization
Southern-Tohoku General Hospital
Division name
Department of Gastroenterology
Zip code
9638563
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima
TEL
0249345322
Homepage URL
ag14072@yahoo.co.jp
Sponsor or person
Institute
Southern-Tohoku General Hospital
Institute
Department
Personal name
Koichi Hamada
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Southern TOHOKU Research Institute for Neuroscience
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima
Tel
0249345322
rinri@mt.strins.or.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
福島県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort
Management information
Registered date
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068237
