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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032151
Receipt No. R000034149
Scientific Title A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer
Date of disclosure of the study information 2018/04/08
Last modified on 2018/04/08

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Basic information
Public title A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer
Acronym A multicenter phase II trial of the applicability and safety of M-NBI for diagnosis of histological type of early gastric cancer
Scientific Title A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer
Scientific Title:Acronym A multicenter phase II trial of the applicability and safety of M-NBI for diagnosis of histological type of early gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to confirm the applicability and safety of adding magnifying narrow-band imaging (M-NBI) to white-light endoscopy in the diagnosis of histological type of early gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint is diagnostic accuracy to distinguish undifferentiated- from differentiated-type early gastric cancer for all targeted lesions.
Key secondary outcomes

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Forceps biopsy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically proven cT1 gastric cancer.
2. Planned to undergo endoscopic resection or gastrectomy in the participant institutions.
3. Aged more than 20 years.
Key exclusion criteria 1. Risk of bleeding after biopsy.
2. History of gastrectomy.
3. Macroscopically, the targeted lesion is elevated type.
4. The size of the targeted lesion is smaller than 5 mm.
5. Erosion or an ulcer in the center of the targeted lesion.
6. Informed consent was not obtained.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenshi Yao
Organization Fukuoka University Chikushi Hospital
Division name Department of Endoscopy
Zip code
Address 1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502, Japan
TEL 092-921-1011
Email yao@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kanesaka
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL 06-6945-1181
Homepage URL
Email takashikanesaka@gmail.com

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization None/Osaka International Cancer Institute
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
Address
Tel
Email

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
2018 Year 04 Month 08 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
2017 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 08 Day
Last modified on
2018 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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