UMIN-CTR Clinical Trial

Basic information
Public title	Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF)
Acronym	Analysis for effect of EPA on ACF
Scientific Title	Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF)
Scientific Title:Acronym	Analysis for effect of EPA on ACF
Region	Japan

Condition
Condition	Subjects with aberrant crypt foci (ACF)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Omega-3 polyunsaturated fatty acids EPA exert a protective effect on the development of colorectal cancer in animal models and cancer cell lines. EPA is marketed as a dietary supplement, and it is authorized as a medicine for hyperlipidemia in Japan. The aim of this study is to examine the effect of EPA on ACF and polyps and to validate the possibility of chemoprevention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Observation of ACF and polyps using magnifying endoscopy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Oral administration of EPA 600mg three times daily for one month.
Interventions/Control_2	No administration of newly drug for one month.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	a. Obtaining informed consent b. Positive for ACF
Key exclusion criteria	a. Liver cirrhosis or chronic hepatic, chronic renal failure b. Women who are pregnant or with a possibility of pregnancy c. Alcohol dependence or drug dependence d. Drug allergy e. Heart failure f. Hemorrhagic g. Those who have started to use other medication or dietary supplement in study period h. The patient that it is already taken EPA i. History of colorectal cancer j. Family history of colorectal cancer k. The patient currently taking NSAIDs l. Inadequate to entry to this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Zip code
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Hirokazu Takahashi
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Zip code
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant from Ministry of Education, Science, Sports and Culture in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2009 Year 02 Month 01 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	2008 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 12 Month 04 Day
Last modified on	2008 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001872

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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