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Phase 0
50 Years
N/A
Not Enrolling
Both
Prevention of Colorectal Cancer

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Trial Information


Inclusion Criteria:



- All non-pregnant patients >50 years of age

Exclusion Criteria:

- The following will be specifically looked for, and result in patients not being
eligible for study enrollment:

- Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60
days of study entry.

- History of chronic IBD or prior pelvic radiation (inflammation distorts crypt
pattern).

- Intake of any selenium supplements within 60 days of study entry, including
vitamins.

- Patients with increased bleeding risk from biopsy protocol (i.e. renal failure,
decompensated cirrhosis, blood dyscrasia).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Reduction in ACF biomarkers

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Richard V Benya, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois

Authority:

United States: Food and Drug Administration

Study ID:

2008-1122

NCT ID:

NCT01211561

Start Date:

December 2010

Completion Date:

December 2016

Related Keywords:

  • Prevention of Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

University of Illinois at Chicago Medical CenterChicago, Illinois  60612