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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047709
Receipt No. R000054399
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.
Date of disclosure of the study information 2022/05/10
Last modified on 2022/05/10

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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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