UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study.
Acronym	Gastric cancer after Helicobacter pylori eradication study.
Scientific Title	Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study.
Scientific Title:Acronym	Gastric cancer after Helicobacter pylori eradication study.
Region	Japan

Condition
Condition	Early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine the endoscopic diagnostic performance of early gastric cancer detected after H. pylori eradication compared with that of gastric cancer presently infected with H. pylori.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the qualitative diagnostic performance of M-NBI observation using the vessel plus surface classification system for early gastric cancer detected after H. pylori eradication and early gastric cancer currently infected with H. pylori.
Key secondary outcomes	1. To compare the qualitative diagnostic performance of conventional white-light observation including dye endoscopic observation using color plus surface classification system for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 2. To compare the diagnostic performance of M-NBI and C-WLI+CE for the horizontal extent of early gastric cancer by M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 3. To compare the diagnostic performance of M-NBI and C-WLI+CE for the diagnosis of gastric carcinoma after H. pylori eradication and gastric carcinoma infected with H. pylori by histopathological classification into low atypia and other lesions. 4. To compare the range diagnostic performance of M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori according to the presence or absence and extent of noncancerous epithelial covering on the surface of intramucosal carcinoma nests.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with early-stage gastric cancer who are scheduled to undergo endoscopic or surgical resection with a diagnosis of Vienna Classification Category 4 or 5 on biopsy histopathology of the lesion. 2. Patients with ECOG-performance status 0 or 1. 3. Patients must be at least 20 years of age at the time of consent. 4. Patients who have given written consent to participate in the study.
Key exclusion criteria	1. Patients with postoperative stomach or gastrointestinal tract. 2. Patients who are determined to be Helicobacter pylori uninfected. 3. Patients who are judged by the physician to have a serious underlying disease such as cerebral infarction or severe heart failure. 4. Patients who are judged by the investigator or subinvestigator to be inappropriate to conduct this study. 5. Patients with gastric cancer detected by endoscopy less than 6 months after Helicobacter pylori eradication.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kenshi Middle name Last name Yao
Organization	Fukuoka University Chikushi Hospital
Division name	Endoscopy
Zip code	8188502
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka Japan
TEL	+81929211011
Email	yao@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Hirase
Organization	Fukuoka University Chikushi Hospital
Division name	Gastroenterology
Zip code	8188502
Address	1-1-1 Zokumyoin Chikushino-city Fukuoka Japan
TEL	+81929211011
Homepage URL
Email	d.r.g.b0116@gmail.com

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi Hospital
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	The ethics committee of Fukuoka University
Address	7-45-1, Nanakuma, Jonan Ward, Fukuoka City, Fukuoka
Tel	+81928011011
Email	fumed-ethics@fukuoka-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	福岡大学筑紫病院(福岡県)

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 10 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	2022 Year 03 Month 28 Day
Date of IRB	2022 Year 03 Month 28 Day
Anticipated trial start date	2022 Year 05 Month 10 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	no related information

Management information
Registered date	2022 Year 05 Month 10 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054399

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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