UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study regarding the correlation between gastrointestinal cancer and life-style related diseases
Title of the study (Brief title)	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	Seiji Adachi
Organization	Gifu University Graduate School of Medicine
Division name	Gastroenterology
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6308
Email	sadachi-gif@umin.ac.jp

Public contact
Name of contact person	Seiji Adachi
Organization	Gifu University Graduate School of Medicine
Division name	Gastroenterology
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6308
Homepage URL
Email	sadachi-gif@umin.ac.jp

Sponsor
Institute	Gifu University Graduate School of Medicine, Gastroenterology
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019437