UMIN-CTR Clinical Trial

Basic information
Public title	Prospective comparative study of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Acronym	Image enhanced endoscopy in early gastric cancer after H. pylori eradication
Scientific Title	Prospective comparative study of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Scientific Title:Acronym	Image enhanced endoscopy in early gastric cancer after H. pylori eradication
Region	Japan

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

Objectives
Narrative objectives1	Prospective evaluation of diagnostic utility of image enhanced endoscopy in the diagnosis of early gastric cancer after H. pylori eradication
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic specificity of gastric cancer in real time endoscopic diagnosis
Key secondary outcomes

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Generation Safety
Key exclusion criteria	1. Those who cannot undergo endoscopic biopsy (hematopoietic diseases etc.) 2. Those who cannot stop antiplatelet or anticoagulant under the guideline of Japan Gastroenterological Endoscopy Society. 3. Those who have severe allergy. 4. Those who have severe lung, kidney and heart diseases. 5. Those who have severe infection. 6. Those who cannot undergo adequate endoscopic examination. 7. Those who the physician considered them no to be suitable to enroll the study.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomomitsu Tahara
Organization	Fujita Health University
Division name	Gastroenterology
Zip code
Address	1-98 dengakugakubo kutsukakecyo toyoake
TEL	0562-93-9240
Email	shokakan@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomomitsu Tahara
Organization	Fujita Health University
Division name	Gastroenterology
Zip code
Address	1-98 dengakugakubo kutsukakecyo toyoake
TEL	0562-93-9240
Homepage URL
Email	ttahara@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
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	YES
Study ID_1	HM18-134
Org. issuing International ID_1	HM18-134
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 07 Month 14 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	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2018 Year 07 Month 14 Day
Last modified on	2020 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038070