UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011504 |
|---|---|
| Receipt number | R000013458 |
| Scientific Title | Association between metabolic syndrome and development of recurrent colon polyps after polypectomy |
| Date of disclosure of the study information | 2013/08/23 |
| Last modified on | 2013/08/16 21:32:54 |
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Basic information
Public title
Association between metabolic syndrome and development of recurrent colon polyps after polypectomy
Acronym
metabolic syndrome and colon polyp recurrence
Scientific Title
Association between metabolic syndrome and development of recurrent colon polyps after polypectomy
Scientific Title:Acronym
metabolic syndrome and colon polyp recurrence
Region
| Japan |
Condition
Condition
colon polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between metabolic syndrome and development of recurrent colon polyps after polypectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of recurrent colon polyps after polypectomy
Key secondary outcomes
1.Risk factors of colon polyp recurrence
2.Association between metabolic syndrome and colon polyp recurrence
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who were resected colon polyps or intramucosal carcinomas at their first colonoscopy for screening
2.Willingness to provide written informed consent
Key exclusion criteria
1.History of colorectal resection or appendectomy
2.carcinoma invading beyond the mucosa
3.History of inflammatory bowel disease
4.Hisotory/Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
5.Patients with a life expectancy of less than 3 years because of severe disease such as cancer, severe liver dysfunction, severe renal dysfunction, severe infection, etc
6.Pregnancy or possibility of pregnancy
7.Patients judged as inappropriate cadidates for the trial by the investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Leo Taniguchi |
Organization
Chigasaki Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
5-15-1, Honson, Chigasaki City, Kanagawa, Japan
TEL
0467-52-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Leo Taniguchi |
Organization
Chigasaki Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
5-15-1, Honson, Chigasaki City, Kanagawa, Japan
TEL
0467-52-1111
Homepage URL
leo.taniguchi@nifty.com
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Chigasaki Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
茅ヶ崎市立病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the colon polyp recurrence at the surveillance colonoscopy
Management information
Registered date
| 2013 | Year | 08 | Month | 16 | Day |
Last modified on
| 2013 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013458
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
