UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032107 |
|---|---|
| Receipt number | R000036087 |
| Scientific Title | Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI) |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2022/04/08 20:29:44 |
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Basic information
Public title
Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI)
Acronym
Comparative trial of diagnositic ability for colorectal tumor of NBI, BLaI and BLiI
Scientific Title
Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI)
Scientific Title:Acronym
Comparative trial of diagnositic ability for colorectal tumor of NBI, BLaI and BLiI
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability of diagnosis of NBI, BLaI and BLiI for colorectal tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Precise diagnosis rate of NBI, BLaI and BLiI for colorectal polyps
Key secondary outcomes
Colorectal tumor is diagnosed to Type1,Type2,Type3 according to NICE(NBI International Colorectal Endoscopic)classification and to Type1,Type2A,Type2B,Type3 according to JNET(Japan NBI expert team)classification
(1)Sensitivity, secificity, PPV, NPV for non neoplastic and neoplastic tumor
(2)Sensitivity, secificity, PPV, NPV for SM deep invasion tumor and CIS, SM sligt invasion tumor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Diagnose colorectal tumor with NBI(Narrow band imaging)
Interventions/Control_2
Diagnose colorectal tumor with BLaI(Blue laser imaging)
Interventions/Control_3
Diagnose colorectal tumor with BLiI(Blue light imaging)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled for endoscopic resection for colorectal tumor
Key exclusion criteria
Patients judged inappropriate for the trial by investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Higurashi |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9Fukuura, Kanazawa, Yokohama, Kanagawa
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
FUJI FILM
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
Yokohama City University Hospital IRB
Address
3-9 Fukuura Kanazawa-ku Yokohama City
Tel
81-45-787-2640
takuma_h@yokohama-cu.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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
no releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
no releasing
Number of participants that the trial has enrolled
230
Results
In non-inferiority test, Laser-BLI and LED-BLI revealed non-inferiority to NBI in all NICE and JNET categories (p<0.001).
Results date posted
| 2021 | Year | 08 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under submission
Date of the first journal publication of results
Baseline Characteristics
patients who underwent endoscopic resection of colorectal tumors.
Participant flow
After an eligibility check, the patients were randomly assigned to NBI, Laser-BLI or LED-BLI at the central registration center by a computer program. Patients underwent ER by one of three endoscopy devices.
Adverse events
None
Outcome measures
Accuracy of each diagnostic category in NICE and JNET for each endoscopic system.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036087
