comparison of barium enema, computed tomographic colonography, and colonoscopy in detecting colon cancer

Conditions: Colorectal Cancer

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.

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.

Eligibility criteria:
disease characteristics: * one of the following must be present: * at least 1 positive fecal occult blood test within the past 6 months * iron deficiency anemia, defined as: * hemoglobin less than 13 g/dl (males) * hemoglobin less than 12 g/dl (females) * ferritin less than 45 g/dl * episode of bright red blood per the rectum * family history of colon cancer or adenoma * one first-degree relative diagnosed with colon cancer or adenoma at age 60 or under or * two first-degree relatives diagnosed with colon cancer or adenoma at any age * no active gastrointestinal hemorrhage, including any of the following: * reported or witnessed hematemesis * melenic stools * melenemesis * multiple episodes of hematochezia within the past 2 months patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * see disease characteristics hepatic: * not specified renal: * not specified cardiovascular: * no myocardial infarction or cerebrovascular accident within the past 6 weeks pulmonary: * no respiratory failure within the past 6 weeks other: * no serious medical disorder (e.g., sepsis) within the past 6 weeks * weight less than 300 pounds * willing and able to undergo endoscopic or radiologic procedures * no need for special precautions in performing endoscopic procedures (e.g., antibiotic prophylaxis or complicated anticoagulation reversal) * no prisoners * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no other concurrent clinical trial participation involving drugs, medical devices, and/or biologics

Keywords: colon cancer rectal cancer