UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001551 |
|---|---|
| Receipt number | R000001872 |
| Scientific Title | Analysis for effect of Eicosapentaenoic acid (EPA) on aberrant crypt foci (ACF) |
| Date of disclosure of the study information | 2009/02/01 |
| Last modified on | 2008/12/08 13:21:35 |
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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
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
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001872
