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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000001551 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Subjects with aberrant crypt foci (ACF) | |
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | a. Obtaining informed consent
b. Positive for ACF |
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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 |
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Target sample size | 100 |
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Name of lead principal investigator |
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Organization | Yokohama City University Graduate School of Medicine | ||||||
Division name | Gastroenterology Division | ||||||
Zip code | |||||||
Address | 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan | ||||||
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Organization | Yokohama City University Graduate School of Medicine | ||||||
Division name | Gastroenterology Division | ||||||
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Address | 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan | ||||||
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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 |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Last modified on |
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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 |