UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013621 |
|---|---|
| Receipt number | R000015904 |
| Scientific Title | Comparative study for evaluation of endoscopic screening for gastric cancer |
| Date of disclosure of the study information | 2014/04/03 |
| Last modified on | 2019/10/09 15:08:03 |
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Basic information
Public title
Comparative study for evaluation of endoscopic screening for gastric cancer
Acronym
Evaluation study of endoscopic screening for gastric cancer
Scientific Title
Comparative study for evaluation of endoscopic screening for gastric cancer
Scientific Title:Acronym
Evaluation study of endoscopic screening for gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of mortality reduction from gastric cancer by endoscopic screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality of gastric cancer
Key secondary outcomes
1) All causes mortality/Mortality of all cancers
2) Incidence of gastric cancer
3) Sensitivity/Specificity
4) Rates of adverse effects
5) Cost-effectiveness ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Upper gastrointestinal endoscopy
Helicobacter pylori antibody
Pepsinogen
Interventions/Control_2
No intervention
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
| 61 | years-old | <= |
Age-upper limit
| 61 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 61 years at first screening year for intervention
2) Inhabitants who have lived in Niigata city for more than 3 years before the first screening for intervention
Key exclusion criteria
1) Any cancer patients
2) Individuals who have participated in gastric cancer screening in Niigata city within 2 years
3) Patient who have been in therapy for any gastric diseases
4) Patients who have any serious disease and have excluded from target of endoscopic screening for gastric cancer
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Hamashima |
Organization
Teikyo University
Division name
Faculty of Medical Technology
Zip code
173-8606
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
03-3964-1211
chamashi@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Hamashima |
Organization
Niigata City Medical Association
Division name
Office of Research for Endoscopic Screening
Zip code
9500914
Address
3-3-11, Shichikuyama, Chuo-ku, Niigata-shi, Niigata
TEL
025-247-8900
Homepage URL
http://www.esgcr.jp/
kenshin@esgcr.jp
Sponsor or person
Institute
Japan Agency for Medical Reaserch and DEvelopment
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reaserch and DEvelopment
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Niigata City Health Community Center
Niigata City Medical Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga Itabashi-ku, Tokyo
Tel
0339641211
turb-office@teikyo-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
新潟市医師会による内視鏡検診実施認定施設（新潟市）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015904
