UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058269 |
|---|---|
| Receipt number | R000066597 |
| Scientific Title | A Survey of Pathological Diagnosis Based on WHO Criteria and Endoscopic Findings of Colorectal Serrated Lesions |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/24 22:37:16 |
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Basic information
Public title
A Survey of Pathological Diagnosis Based on WHO Criteria and Endoscopic Findings of Colorectal Serrated Lesions
Acronym
Pathology and Endoscopy of Colorectal Serrated Lesions
Scientific Title
A Survey of Pathological Diagnosis Based on WHO Criteria and Endoscopic Findings of Colorectal Serrated Lesions
Scientific Title:Acronym
Pathology and Endoscopy of Colorectal Serrated Lesions
Region
| Japan |
Condition
Condition
colorectal serrated lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the clinical impact of the 2019 WHO classification update by examining changes in the frequency and features of serrated lesions, especially SSAP and SSL, before and after the revision.
Basic objectives2
Others
Basic objectives -Others
Investigate the impact of changes in diagnostic criteria
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of SSAP or SSL per colonoscopy
Key secondary outcomes
1. Maximum diameter of SSAP or SSL
2. Morphology of SSAP or SSL (protruded type or flat type)
3. Location of SSAP or SSL detection (right colon, left colon, or rectum)
4. Presence of dysplasia in SSAP or SSL
5. Frequency, maximum diameter, morphology, detection site, and presence of dysplasia in serrated lesions other than SSAP or SSL
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
Patients diagnosed with colorectal serrated lesions based on the 2010 WHO diagnostic criteria between May 2013 and August 2018, and based on the 2019 WHO diagnostic criteria between January 2020 and December 2024.
Key exclusion criteria
Patients diagnosed with serrated lesions between September 2018 and December 2019
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology, Aizu Medical Center
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu-city
TEL
0242-75-2100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology, Aizu Medical Center
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu-city
TEL
0242-75-2100
Homepage URL
https://fmu.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=995
togashik@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical 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
Institusional Review Board, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-city
Tel
024-547-1111
fmurec@fmu.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 | 06 | 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
| 2025 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Data on patients who may meet the eligibility criteria will be collected and compiled using the hospital database.
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066597
