UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047156 |
|---|---|
| Receipt number | R000053793 |
| Scientific Title | Randomized comparative study of third-generation Narrow band imaging (NBI) and White light imaging (WLI) in the diagnosis of the presence of early gastric cancer. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/09/12 10:47:06 |
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Basic information
Public title
Randomized comparative study of third-generation Narrow band imaging (NBI) and White light imaging (WLI) in the diagnosis of the presence of early gastric cancer.
Acronym
Detection of early gastric cancer by 3rd generation NBI
Scientific Title
Randomized comparative study of third-generation Narrow band imaging (NBI) and White light imaging (WLI) in the diagnosis of the presence of early gastric cancer.
Scientific Title:Acronym
Detection of early gastric cancer by 3rd generation NBI
Region
| Japan |
Condition
Condition
Early stage gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Proof that Third Generation NBI Non-Expanded Observation is More Useful than WLI Observation in Diagnosing the Presence of Early Gastric Cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection rate of early gastric cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Prior WLI observation and posterior NBI non-expanded observation
Interventions/Control_2
Prior NBI non-expansion observation and posterior WLI observation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with curative resection who underwent endoscopic treatment for early stage gastric cancer
Key exclusion criteria
Post gastrectomy
Endoscopic treatment non curative resection
Target sample size
566
Research contact person
Name of lead principal investigator
| 1st name | Yukihisa |
| Middle name | |
| Last name | Fujinaga |
Organization
Nara Medical University
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
3naika@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihisa |
| Middle name | |
| Last name | Fujinaga |
Organization
Nara Medical University
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
3naika@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
Nara Medical University Medical Ethics Review Committee
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.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
| 2022 | Year | 04 | Month | 01 | 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
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053793
