UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016748 |
|---|---|
| Receipt number | R000019437 |
| Scientific Title | A prospective cohort study regarding the correlation between gastrointestinal cancer and life-style related diseases |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/05/31 15:01:57 |
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Basic information
Public title
A prospective cohort study regarding the correlation between gastrointestinal cancer and life-style related diseases
Acronym
A study regarding the correlation between gastrointestinal cancer and life-style related diseases
Scientific Title
A prospective cohort study regarding the correlation between gastrointestinal cancer and life-style related diseases
Scientific Title:Acronym
A study regarding the correlation between gastrointestinal cancer and life-style related diseases
Region
| Japan |
Condition
Condition
Esophageal cancer, Gastric cancer, Liver cancer, Colorectal cancer, Pancreatic cancer, Biliary cancer, disease in GI tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between gastrointestinal disease (including cancer) and life-style related diseases
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate (prevalence) of gastrointestinal disease (including cancer) in patients with life-style related diseases
Key secondary outcomes
Correlation between gastrointestinal disease (including cancer) and medications for life-style related diseases
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
The subject who agreed to the purpose of this study in the patients visiting to Gifu University Hopsital, Gihoku Kosei Hospital and Nishimino Kosei Hospital.
Key exclusion criteria
The subject who did not agree to the purpose of this study in the patients visiting to Gifu University Hopsital, Gihoku Kosei Hospital and Nishimino Kosei Hospital.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Adachi |
Organization
Gifu University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
sadachi-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Adachi |
Organization
Gifu University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
sadachi-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine, Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine, Regional Cancer Control
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
岐阜大学病院、岐北厚生病院、西美濃厚生病院
Other administrative information
Date of disclosure of the study information
| 2015 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
We are planning to elicidate
1) whether anti-platelet agents increases the detection rate of colorectal cancer by fecal occult blood test, since they cause bleeding tendency.
2) whether anti-diabetes mellitus agents reduce the prevalence of gastrointestinal cancers, since they can improve the resistance to insulin.
Management information
Registered date
| 2015 | Year | 03 | Month | 09 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019437
