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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000461
Receipt No. 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

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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
Email

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
Email tokudome@med.nagoya-cu.ac.jp

Sponsor
Institute DIPP Study group
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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