UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological study on the association between obesity and risk for colorectal polyp and cancer
Title of the study (Brief title)	Obesity and colorectal cancer/adenoma
Region	Japan

Condition
Condition	Colorectal adenoma and cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association between obesity and colorectal adenoma/cancer in the Japanese population
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of colorectal adenoma and cancer in individuals with/without obesity
Key secondary outcomes	The association between disorder of lipid or glucose metabolism, or insulin resistance and colorectal adenoma/cancer development

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who first underwent colonoscopy
Key exclusion criteria	(1)Patients with having a past history of colectomy or rectectomy (2)Patients who have determined by the physicians to have any reasons of unqualified
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroto Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gasstroenterology, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya
TEL	0798-45-6662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	Jiro Watari
Organization	Hyogo College of Medicine
Division name	Division of Gasstroenterology, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya
TEL	0798-45-6662
Homepage URL
Email	watarij@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine, Division of Gasstroenterology, Department of Internal Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hyogo College of Medicine, Division of Gasstroenterology, Department of Internal Medicine
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	No special instruction

Management information
Registered date	2016 Year 04 Month 10 Day
Last modified on	2016 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025202