UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054405 |
|---|---|
| Receipt number | R000062125 |
| Scientific Title | andomized controlled trial of the third generation Narrow Band Imaging compared with White Light Imaging for detection of same early gastric cancer |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2024/05/15 21:17:38 |
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Basic information
Public title
Randomized controlled trial of the third generation Narrow Band Imaging compared with White Light Imaging for detection of same early gastric cancer
Acronym
Randomized controlled trial of NBI compared with WLI for detection of same early gastric cancer (Same EGC Detection trial)
Scientific Title
andomized controlled trial of the third generation Narrow Band Imaging compared with White Light Imaging for detection of same early gastric cancer
Scientific Title:Acronym
Randomized controlled trial of NBI compared with WLI for detection of same early gastric cancer (Same EGC Detection trial)
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the third generation narrow band imaging (NBI) for detection of same early gastric cancer in a randomized controlled trial comparing white light imaging (WLI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of early gastric cancer when the site of lesion or other information is not known at the time of examination
Key secondary outcomes
(1)Detection rate of new lesions
(2)Characteristics of missed lesions
(3)Adverse event rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NBI followed by WLI
Interventions/Control_2
WLI followed by NBI
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients whose endoscopy is performed for the present gastric cancer or adenoma
Key exclusion criteria
(1)Gastrectomy patients
(2)Patients who have reconstructed gastric tube
(3)Patients with severe underlying disease
(4)Patients taking medicines which cause the trouble in obtaining a biopsy tissue
(5)Patients who undergo urgent endoscopy
(6)Patients whom a researcher judges to be inappropriate as a subject
(7)Patients with multiple lesions detected
(8)Patients with no detectable therapeutic target lesions
Target sample size
241
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Chiba, MD, PhD |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
1438527
Address
4-30-1 Chuo, Ota-ku, Tokyo
TEL
0337753111
hchiba04@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kuwabara |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
1438527
Address
4-30-1 Chuo, Ota-ku, Tokyo
TEL
0337753111
Homepage URL
kuwabara612@gmail.com
Sponsor or person
Institute
Omori Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Omori Red Cross Hospital
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
Omori Red Cross Hospital
Address
4-30-1 Chuo, Ota-ku, Tokyo
Tel
0337753111
kuwabara612@gmail.com
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
| 2024 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062125
