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


Phase 3
50 Years
N/A
Open (Enrolling)
Male
Colorectal Cancer, Precancerous Condition

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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 CenterTucson, Arizona  85724