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Brief Title: Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
Official Title: Prospective Comparison of Air Contrast Barium Enema (ACBE), Computed Tomographic Colonography (Virtual Colonoscopy) and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood
Study ID: NCT00016029
Brief Summary: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer. PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
Detailed Description: OBJECTIVES: * Compare the accuracy of air contrast barium enema, computed tomographic colonography (virtual colonoscopy), and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer. * Compare the patient experience during each of these imaging tests. OUTLINE: This is a multicenter study. A repeat fecal occult blood test is performed. Patients then undergo an air contrast barium enema (ACBE). At 7-10 days after ACBE, patients undergo a computed tomographic colonography (virtual colonoscopy) followed by a colonoscopy on the same day. A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy. If the repeat ACBE continues to show an abnormality, patients undergo a second colonoscopy. Within 24 hours of completion of each test, patients fill out a questionnaire about their experience. At 5-7 days after completion of all tests, patients complete a final questionnaire comparing all 3 tests. PROJECTED ACCRUAL: A total of 2,133 patients will be accrued for this study within 4 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
California Pacific Medical Center - Pacific Campus, San Francisco, California, United States
California Pacific Medical Center - California Campus, San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
Indian River Radiology, Vero Beach, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Troy Internal Medicine, P.C., Troy, Michigan, United States
Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Massey Cancer Center, Richmond, Virginia, United States
Name: Don Rockey, MD
Affiliation: Duke Cancer Institute
Role: STUDY_CHAIR