Colon Cancer Clinical Trial
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000
Summary
RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.
PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
Full Description
OBJECTIVES:
Primary
To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
To assess the effect of selenium on colorectal cancer (CRC) incidence.
Secondary
To assess the effect of vitamin E on CRA occurrence.
To assess the effect of vitamin E on CRC incidence.
Tertiary
To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
To explore the effect modification of selenium and vitamin E by body mass index.
OUTLINE: This is a multicenter study.
Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.
Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.
Participants are followed annually.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial
PATIENT CHARACTERISTICS:
Willing to sign an applicable medical records release form
Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
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There is 1 Location for this study
Tucson Arizona, 86724, United States
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