UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021856 |
|---|---|
| Receipt number | 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 16:57:34 |
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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
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
watarij@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine,
Division of Gasstroenterology,
Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025202
