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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01211561 |
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Date of registration:
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28/09/2010 |
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Primary sponsor: |
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Public title:
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Colon Cancer Prevention Using Selenium
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Scientific title:
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Date of first enrolment:
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December 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01211561 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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John OToole, BA |
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Address:
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Telephone:
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312-413-2446 |
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Email:
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Affiliation:
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Name:
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John A O'Toole, BA |
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Address:
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Telephone:
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312-413-2446 |
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Email:
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jotool2@uic.edu |
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Affiliation:
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Name:
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Richard V Benya, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Illinois |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All non-pregnant patients >50 years of age
Exclusion Criteria:
- The following will be specifically looked for, and result in patients not being
eligible for study enrollment:
- Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60
days of study entry.
- History of chronic IBD or prior pelvic radiation (inflammation distorts crypt
pattern).
- Intake of any selenium supplements within 60 days of study entry, including
vitamins.
- Patients with increased bleeding risk from biopsy protocol (i.e. renal failure,
decompensated cirrhosis, blood dyscrasia).
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prevention of Colorectal Cancer
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Intervention(s)
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Drug: placebo
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Drug: Selenium, selenomethionine
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Primary Outcome(s)
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Reduction in ACF biomarkers
[Time Frame: 6 months]
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Secondary ID(s)
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2008-1122
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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