Colorectal Cancer Clinical Trial
Official title:
S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
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.
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.
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