Expired Study
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Tucson, Arizona 86724


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00706121


Primary Contact:

Principal Investigator
M. Peter Lance, MD
University of Arizona


Backup Contact:

N/A


Location Contact:

Tucson, Arizona 86724
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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