UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006391 |
|---|---|
| Receipt number | R000007583 |
| Scientific Title | The research on how the gastric cancer screening should be evaluated - Examination on afternoon gastric cancer screening and gastric ABC screening - |
| Date of disclosure of the study information | 2011/09/22 |
| Last modified on | 2013/10/28 15:42:21 |
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Basic information
Public title
The research on how the gastric cancer screening should be evaluated - Examination on afternoon gastric cancer screening and gastric ABC screening -
Acronym
Examination on afternoon gastric cancer screening
Scientific Title
The research on how the gastric cancer screening should be evaluated - Examination on afternoon gastric cancer screening and gastric ABC screening -
Scientific Title:Acronym
Examination on afternoon gastric cancer screening
Region
| Japan |
Condition
Condition
Of 321 staff at Kawasaki Hospital of Kawasaki Medical School who are registered as subjects for gastric cancer screening
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With regard to a new screening method to perform gastric radiography in the afternoon, we will examine planning of this evaluation research and its experimental implementation, and through these works, we will research how the gastric cancer screening should be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric radiography has been performed in the afternoon in reading evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group A:
Serum pepsinogen test negative case, Helicobacter pylori negative case
Interventions/Control_2
Group B:
Serum pepsinogen test negative case, Helicobacter pylori positive case
Interventions/Control_3
Group C:
Serum pepsinogen test positive case
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Group A
(Serum pepsinogen test negative case, Helicobacter pylori negative case)
2.Group B
(Serum pepsinogen test negative case, Helicobacter pylori positive case)
Key exclusion criteria
1.Group C
(Serum pepsinogen test positive case)
2.Subjects with malignancy in other organ
3.Subjects with having a history of gastrectomy
4.Subjects who have determined by the physicians to have any reasons of unqualified
Target sample size
321
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Sato |
Organization
Kawasaki Medical School
Division name
Department of Health Care Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-225-2111
yumi-sato@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Sato |
Organization
Kawasaki Hospital, Kawasaki Medical School
Division name
Health Care Center
Zip code
Address
2-1-80 Nakasange, Kita-ku, Okayama-shi
TEL
086-225-2111
Homepage URL
yumi-sato@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Hospital, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2011 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | 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
| 2011 | Year | 09 | Month | 22 | Day |
Last modified on
| 2013 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007583
