UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056765 |
|---|---|
| Receipt number | R000064878 |
| Scientific Title | Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2025/01/20 22:06:54 |
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Basic information
Public title
Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions
Acronym
Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions
Scientific Title
Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions
Scientific Title:Acronym
Prevalence and endoscopic predictioN of sessile serrated lesion with dysplasia and submucosal Invasive cancer in large sessile lesions
Region
| Japan |
Condition
Condition
Serrated lesions larger than 20 mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively register serrated lesions larger than 20mm and evaluate the prevalence of SSLD and submucosal invasive cancer in resected specimens, as well as the diagnostic accuracy of endoscopic assessment for these conditions.
Basic objectives2
Others
Basic objectives -Others
Prevalence and endoscopic prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative predictive value of endoscopic assessment for submucosal invasive cancer in SL lesions
Key secondary outcomes
1. Negative predictive value of endoscopic assessment for SSLD
2. Prevalence of SSLD/submucosal invasive cancer in endoscopically diagnosed SSL lesions
3. Proportion of endoscopically diagnosed SSL among pathologically confirmed SSL
4. Correlation between endoscopic features (nodularity/double elevation/central depression) and SSLD/invasive cancer location
5. Sensitivity of endoscopic diagnosis for pathological SSLD/submucosal invasive cancer
6. Adverse event rate (delayed bleeding, perforation)
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 endoscopically diagnosed serrated lesions larger than 20mm
2. 18 years or older at the time of consent
3. Written informed consent obtained from the patient
Key exclusion criteria
1. Residual/recurrent lesions previously attempted for endoscopic resection
2. Patients with inflammatory bowel disease
3. Patients with polyposis syndrome
4. Pregnant women or those planning pregnancy during the study period
5. Patients deemed inappropriate for the study by the principal investigator
Target sample size
482
Research contact person
Name of lead principal investigator
| 1st name | Imai |
| Middle name | |
| Last name | Kenichiro |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
81-55-989-5222
k.imai1977@gmail.com
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Okumura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa
TEL
81-45-949-7000
Homepage URL
javier.thierry@gmail.com
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
81-55-989-5222
tansaku_office@scchr.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 | 21 | 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 | 07 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Prospective Observational Study
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064878
