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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | gastric cancer | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
ishibashi@tsurukamekai.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |