UMIN ID: UMIN000001265
Registered date:24/07/2008
Pilot study of chemopreventive effect of pioglitazone for colorectal cancer using aberrant crypt foci as a biomarker
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Subjects with aberrant crypt foci (ACF) |
| Date of first enrollment | 2004/04/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Oral administration of pioglitazone in 15mg daily. No administration of newly drug. |
Outcome(s)
| Primary Outcome | Observation of ACF using magnifying endoscopy |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. Those who have started to use different medication for diabetes mellitus from pioglitazone-alone (including insulin) in study period g. The patient that it is already taken pioglitazone h. History of cancer i. Family history of colorectal cancer j. The patient currently taking NSAIDs k. Inadequate to entry to this study |
Related Information
| Primary Sponsor | Gastroenterology Division, Yokohama City University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant from Ministry of Education, Science, Sports and Culture in Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hirokazu Takahashi |
| Address | 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan Japan |
| Telephone | |
| Affiliation | Yokohama City University Graduate School of Medicine Gastroenterology Division |
| scientific contact | |
| Name | Atsushi Nakajima |
| Address | 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan Japan |
| Telephone | |
| Affiliation | Yokohama City University Graduate School of Medicine Gastroenterology Division |