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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042991
Receipt No. R000049084
Scientific Title The efficacy of double-check system for improving the detection rate of interval gastric cancer
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/13

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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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