Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Colorectal Cancer||Other: screening questionnaire administration Procedure: barium enema injection Procedure: computed tomography Procedure: computed tomography colonography Procedure: diagnostic colonoscopy Procedure: screening colonoscopy|
- 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|
|Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|