S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
50 Years
N/A
Male
Colorectal Cancer, Precancerous Condition
Trial Information
S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Effect of selenium on colorectal adenoma (CRA) occurrence and colorectal cancer (CRC) incidence
Outcome Time Frame:
Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months
Safety Issue:
No
Principal Investigator
M. Peter Lance, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Arizona
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000593329
NCT ID:
NCT00706121
Start Date:
June 2008
Completion Date:
December 2014
Related Keywords:
- Colorectal Cancer
- Precancerous Condition
- colon cancer
- rectal cancer
- adenomatous polyp
- Colorectal Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
