UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of double-check system for improving the detection rate of interval gastric cancer
Acronym	The efficacy of double-check system for improving the detection rate of interval gastric cancer
Scientific Title	The efficacy of double-check system for improving the detection rate of interval gastric cancer
Scientific Title:Acronym	The efficacy of double-check system for improving the detection rate of interval gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To verify that the establishment of an endoscopic double-check system improves the detection rate of interval cancers detected within 5 years of the last endoscopic examination.
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	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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have undergone upper gastrointestinal endoscopy in the facility as part of a health checkup or outpatient care, and who have had the examination in the same facility within the past 5 years.
Key exclusion criteria	Those who were unable to complete the endoscopy for any reason.
Target sample size	40000

Research contact person
Name of lead principal investigator	1st name Fumiaki Middle name Last name Ishibashi
Organization	Koganei Tsurukame Clinic
Division name	Endoscopy center
Zip code	184-0004
Address	6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Email	ishibashi@tsurukamekai.jp

Public contact
Name of contact person	1st name Midori Middle name Last name Shinoki
Organization	Koganei Tsurukame Clinic
Division name	Secretariat of Center for Clinical Research
Zip code	184-0004
Address	6-14-28-3F, Honcho, Koganei-shi, Tokyo
TEL	042-386-3757
Homepage URL
Email	shinoki@tsurukamekai.jp

Sponsor
Institute	Center for Clinical Research
Institute
Department

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	Shinjuku Tsurukame Clinic
Address	2-11-15-3F, Yoyogi, Shibuya-ku, Tokyo
Tel	03-3299-0077
Email	ando@tsurukamekai.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	2021 Year 01 Month 13 Day

Related information
URL releasing protocol	https://koganei.tsurukamekai.jp/user/media/koganei-clinic/page/about/irb/plan1902.pdf
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	40000
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	No longer recruiting
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 07 Month 14 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We introduced a double-check system in August 2018 and analyze the change in early interval cancer detection rate in the 2 years before and after the introduction of the system.

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049084

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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