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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021856
Receipt No. R000025202
Scientific Title Epidemiological study on the association between obesity and risk for colorectal polyp and cancer
Date of disclosure of the study information 2016/04/10
Last modified on 2016/04/10

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Basic information
Public title Epidemiological study on the association between obesity and risk for colorectal polyp and cancer
Acronym Obesity and colorectal cancer/adenoma
Scientific Title Epidemiological study on the association between obesity and risk for colorectal polyp and cancer
Scientific Title:Acronym 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

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 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
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gasstroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6662
Email miwahgi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gasstroenterology, Department of Internal Medicine
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000025202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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