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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 3, 2001 |
| Last Updated Date | January 20, 2009 |
| Start Date ICMJE | October 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00018551 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Chemoprevention With Folic Acid |
| Official Title ICMJE | 3389 Colorectal Adenoma: Chemoprevention With Folic Acid |
| Brief Summary | Colorectal neoplasia is the second most common cancer in the United States and other Western countries with about 140,000 newly diagnosed cases per year in the United States with a mortality rate of about 40%. The identification of a specific natural or synthetic compound with the ability to reverse or suppress the process of colon carcinogenesis would have profound implication in the development of colorectal adenomas and their subsequent transformation to colon cancer. Furthermore, the establishment of a correlative relationship between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence would provide pivotal data required to elucidate cell signaling mechanisms in future colon cancer chemoprevention trials. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Folic Acid |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | September 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Asymptomatic individuals from the age of 18 -80 years, undergoing clinically indicated colonoscopy for colon polyps noted on screening flexible sigmoidoscopy or as routine surveillance for a history of colon polyps, who are found to have at least one adenoma > 0.5cm will be eligible for entry. |
| Gender | Both |
| Ages | 18 Years to 80 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00018551 |
| Responsible Party | |
| Study ID Numbers ICMJE | ONCO-021-98S |
| Study Sponsor ICMJE | Department of Veterans Affairs |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | December 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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