UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000461 |
|---|---|
| Receipt number | R000000534 |
| Scientific Title | Dietary intervention in patients polypectomized for tumors of the colorectum |
| Date of disclosure of the study information | 2006/08/03 |
| Last modified on | 2007/05/05 12:34:58 |
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Basic information
Public title
Dietary intervention in patients polypectomized for tumors of the colorectum
Acronym
DIPP Study
Scientific Title
Dietary intervention in patients polypectomized for tumors of the colorectum
Scientific Title:Acronym
DIPP Study
Region
| Japan |
Condition
Condition
Adenomas and cancer in adenoma of the colorectum
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of dietary intervention with regard to the consumption of fatty acids, in particular, on the subsequent incidence, number and size of colorectal tumors in patients polypectomized for tumors of the colorectum
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of colorectal tumors
Key secondary outcomes
Number/multiplicity, size and pathologic type of colorectal tumors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Decrease in consumption of total fat
Decrease in consumption of n-6PUFAs
Increase in consumption of n-3PUFAs
Interventions/Control_2
Decrease in consumption of total fat
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients polypectomized for tumors of the colorectum
Key exclusion criteria
Patients with bleeding diathesis, FAP (familial adenomatous polyposis) and HNPCC (hereditary non-polyposis colorectal cancer) and past histories of colorectal cancer, gastrectomy and cholecystectomy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokudome, Shinkan |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Public Health
Zip code
Address
1 Kwasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8174
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokudome, Shinkan |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Public Health
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8174
Homepage URL
tokudome@med.nagoya-cu.ac.jp
Sponsor or person
Institute
DIPP Study group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology, Japan
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
| 2006 | Year | 08 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 1995 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 1996 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Protocol was published in the article as follows: Tokudome, S. et al. Rationale and study design of dietary intervention in patients polypectomized for tumors of the colorectum. Jpn. J. Clin. Oncol. 32: 550-553, 2002.
Management information
Registered date
| 2006 | Year | 08 | Month | 03 | Day |
Last modified on
| 2007 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
