S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
- 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.
- To assess the effect of vitamin E on CRA occurrence.
- To assess the effect of vitamin E on CRC incidence.
- To explore the effect modification of selenium and vitamin E by aspirin on CRA
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Effect of selenium on colorectal adenoma (CRA) occurrence and colorectal cancer (CRC) incidence
Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months
M. Peter Lance, MD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center||Tucson, Arizona 85724|