UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025839 |
|---|---|
| Receipt number | R000029627 |
| Scientific Title | Research on development of gastric cancer screening system based on individual risk |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/10/09 15:10:18 |
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Basic information
Public title
Research on development of gastric cancer screening system based on individual risk
Acronym
Research on gastric cancer screening based on individual risk
Scientific Title
Research on development of gastric cancer screening system based on individual risk
Scientific Title:Acronym
Research on gastric cancer screening based on individual risk
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Screening interval extension of gastric cancer screening for low-risk group for gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative incidence of gastric cancer
Key secondary outcomes
Sensitivity, specificity, rate of adverse effects
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Helicobacter pylori antibody (baseline, 1 time)
Interventions/Control_2
Serum pepsinogen (baseline, 1 time)
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)50 years to 69 years at baseline screening for gastric cancer
2)Obtaining informed consent for participation in research screening
Key exclusion criteria
1) having serious diseases
2) having any treatments for cancers
3) having any gastric disease
4) participants in the preceding study in Niigata city
Target sample size
47100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Fukao |
Organization
Miyagi Cancer Association
Division name
Research Devision
Zip code
980-0011
Address
5-7-30 Kamizugi Sendai
TEL
022-263-1525
afukao@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Hamashima |
Organization
Teikyo University
Division name
Faculty of Medical Techmology
Zip code
1738606
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
0339641211
Homepage URL
http://j-sasg.jp/
chamashi@med.teikyo-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyagi Cancer Association
Address
5-7-30 Kamisugi Aiba-ku Sendai
Tel
022-263-1525
kkato@st.cat-v.ne.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
宮城県対がん協会（宮城県）、新潟市医師会、鳥取東部医師会（鳥取市）、鳥取西部医師会（米子市）盛岡市医師会、前橋市医師会、金沢市医師会、JA秋田県厚生連由利組合病院（秋田県由利本荘市）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2017 | Year | 01 | Month | 25 | 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=R000029627
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
