S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000

Phase

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Precancerous Condition

Treatment

N/A

Clinical Study ID

NCT00706121

CDR0000593329

S0000D

U10CA037429

Ages 50-120
Male
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

June 01, 2008

January 31, 2018

Study 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.

Connect with a study center

Arizona Cancer Center
Tucson, Arizona 86724
United States
Site Not Available

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