Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
|ClinicalTrials.gov Identifier: NCT00016029|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : March 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: screening questionnaire administration Procedure: barium enema injection Procedure: computed tomography Procedure: computed tomography colonography Procedure: diagnostic colonoscopy Procedure: screening colonoscopy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||775 participants|
|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 Start Date :||August 2000|
|Actual Study Completion Date :||August 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016029
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|California Pacific Medical Center - Pacific Campus|
|San Francisco, California, United States, 94115|
|California Pacific Medical Center - California Campus|
|San Francisco, California, United States, 94118-1618|
|Veterans Affairs Medical Center - San Francisco|
|San Francisco, California, United States, 94121|
|United States, Florida|
|Indian River Radiology|
|Vero Beach, Florida, United States, 32960|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Michigan|
|Troy Internal Medicine, P.C.|
|Troy, Michigan, United States, 48098|
|United States, New Jersey|
|Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Veterans Affairs Medical Center - Durham|
|Durham, North Carolina, United States, 27705|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Don Rockey, MD||Duke Cancer Institute|