UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048393 |
|---|---|
| Receipt number | R000055162 |
| Scientific Title | Dual-focus versus conventional magnification endoscopy with narrow-band imaging for the optical diagnosis in Large Colorectal Polyps: an image-based pilot study |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2025/02/21 18:27:14 |
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Basic information
Public title
X1 study
Acronym
X1 study
Scientific Title
Dual-focus versus conventional magnification endoscopy with narrow-band imaging for the optical diagnosis in Large Colorectal Polyps: an image-based pilot study
Scientific Title:Acronym
X1-JNET study 1
Region
| Japan |
Condition
Condition
Colon polyp
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic yield of Dual-Focus versus Full-Zoom magnified endoscopy with narrow-band imaging (NBI) for colorectal polyps larger than 10 mm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity for pT1b cancer in Dual-Focus and Full-Zoom magnified NBI endoscopy
Key secondary outcomes
The concordance between the histology and magnified NBI findings according to Japan NBI expert Team (JNET) cllasification
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic magnified observation with NBI
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
Cases undergo colonoscopy using the X-1 endoscopy system and new endoscopies (CF-XZ1200I or CF-EZ1500DI) at Shizuoka Cancer Center, Sano Hospital, and Kyoto Second Red Cross Hospital
Key exclusion criteria
1. Cases with inflammatory bowel disease or with polyposis syndrome
2. Cases with blood coagulation dysfunction or with unavailable suspension of anticoagulants
3. Cases deemed unsuitable as a subject in the study by the investigator for some other reason
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
ke.imai@scchr.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ke.imai@scchr.jp
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee of Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
rinsho_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
| 2022 | Year | 07 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055162
