Colon Cancer Clinical Trial
The National CT Colonography Trial
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.
Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
Determine the effects of different colon preparations on the accuracy of CTC in these participants.
Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.
OUTLINE: This is a multicenter study.
Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.
Participants are followed up for approximately 4 weeks.
PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Male or female outpatients
Aged 50 years or older
Scheduled for screening colonoscopy
Participant's signed informed consent
Symptoms of disease of the lower gastrointestinal tract, including
Melanotic stools or/and hematochezia on more than one occasion in the previous six months
Lower abdominal pain that would normally require a medical evaluation
Inflammatory bowel disease and/or familial polyposis syndrome
Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
Previous colonoscopy within the past five years
Anemia (hemoglobin less than 10 gm/dl)
Positive fecal occult blood test (FOBT)
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There are 14 Locations for this study
Scottsdale Arizona, 85259, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
San Francisco California, 94121, United States
Englewood Colorado, 80112, United States
New Haven Connecticut, 06520, United States
Chicago Illinois, 60637, United States
Springfield Illinois, 62781, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
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