Selenium for Prevention of Adenomatous Colorectal Polyps (NCT00078897) | Clinical Trial Compass
TerminatedPhase 3
Selenium for Prevention of Adenomatous Colorectal Polyps
Stopped: Concluded - Terminated by PI
United States1,621 participantsStarted 2005-01-20
Plain-language summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenomatous polyps
* Meets the following criteria by colonoscopy (performed within the past 6 months):
* Cecum was totally visualized or reached
* At least 90% visualization of colon surface area
* Removed at least 1 adenomatous polyp of at least 3 mm in size during procedure (For the Advanced Adenoma Sub-study: Removal of at least 1 advanced colorectal adenomatous polyp during procedure. An adenoma is considered advanced if it is 10 mm or greater in size, and/or has villous histology and/or shows high grade dysplasia)
* Removed no more than 10 adenomatous polyps of any size by endoscopy
* All other neoplastic and non-neoplastic colon polyps must have been completely removed (except for diminutive \[less than 3 mm\] sessile rectal polyps)
* For the sub-study, at least 1 advanced adenomatous polyp defined as 10 mm or greater in size and/or has villous histology and/or shows high grade dysplasia
* No prior diagnosis of any of the following:
* Colorectal cancer
* Familial adenomatous polyposis
* Ulcerative colitis
* Crohn's disease
* Hereditary non-polyposis colon cancer (HNPCC), defined as:
* Histologically confirmed colorectal cancer in at least 3 relatives, 1 of whom is a first-degree relative of the other 2
* Disease occurrence in at least 2 consecutive generations
* Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age
* Patients wit…
What they're measuring
1
Number of Recurrent Adenomas at Surveillance Colonoscopy
Timeframe: 3 to 5 years after baseline colonoscopy