Clinical Trials

3 studies in Colorectal Polyps

1. Selenium for Prevention of Adenomatous Colorectal Polyps Scottsdale and Phoenix, AZ View Summary
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   Selenium for Prevention of Adenomatous Colorectal Polyps

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps, in terms of histologic type, degree of dysplasia, number, size, and location, in patients with adenomatous colorectal polyps. - Compare the type, incidence, and outcome of side effects in patients treated with these regimens. - Determine patient adherence to long-term treatment with these regimens. Secondary - Determine the effects of regimen modification by baseline blood selenium level, low-dose aspirin, selenoprotein genetic marker polymorphisms (e.g., GPx-1, GPx-2, and SEP15) - Determine the effects of low-dose aspirin (81 mg/day) modification by ornithine decarboxylase promoter genotype, and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (≤ 81 mg/day) aspirin (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral selenium once daily. - Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for up to 5 years* in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up colonoscopy approximately 5 years* after baseline colonoscopy. NOTE: Some patients will continue participation for up to 7 and a half years PROJECTED ACCRUAL: A total of 1,600 patients with an adenoma will be randomized to this study, followed by a second group of randomization of 200 patients with at least one advanced adenoma (at baseline) for a substudy. Total planned randomizations = 1,800 participants.

   NCT ID:

   NCT00078897

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   Who can I contact for additional information about this study?

   
   Scottsdale: Narcelle Jean-Louis 480-301-4714
                       
   
   

2. Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging Jacksonville, FL View Summary
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   Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Information will be collected. Images will be taken.

   NCT ID:

   NCT01354873

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   Who can I contact for additional information about this study?

   
   
   Jacksonville: Grace Staggs, RN,CCRC 904-953-8509
                       
   

3. Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs) Jacksonville, FL View Summary
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   Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Telomeres are the repetitive DNA sequences that cap both ends of chromosomes. Shortening of peripheral blood lymphocyte (PBL) telomeres has been associated with renal and other cancers. The investigators' preliminary data shows an association between shorter PBL telomere length and ACPs. I. Specific Aims 1. Develop a DNA and data repository from individuals with advanced colon polyps (ACPs) and controls 2. Confirm that individuals 50 to 60 years of age with ACPs tend to have shorter peripheral blood lymphocyte (PBL) telomeres than those without ACPs 3. Identify a potential optimal PBL telomere length cut-off to differentiate between individuals with ACPs and those without for evaluation in a larger scale study The over reaching long term goal is to decrease disease and death from colorectal cancer (CRC) using a biomarker strategy to target colonoscopy to those at higher risk.

   NCT ID:

   NCT01062035

   IRB Number:

   09-000131

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