Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: screening questionnaire administration
* Procedure: barium enema injection
* Procedure: computed tomography
* Procedure: computed tomography colonography
* Procedure: diagnostic colonoscopy
* Procedure: screening colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: screening questionnaire administration|nan|
|Procedure: barium enema injection|nan|
|Procedure: computed tomography|nan|
|Procedure: computed tomography colonography|nan|
|Procedure: diagnostic colonoscopy|nan|
|Procedure: screening colonoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer