Unprepped CT Colonography

Study Overview
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Brief Summary
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It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

Detailed Description
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To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Official Title
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CTC of the Unprepped Colon: Optimization & Validation

Conditions
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Colorectal Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications: Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency. Age ≥ 40 -100 years Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160) Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency. Exclusion Criteria: Less than 1/2 of colorectum remaining Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis) Familial Polyposis Melena, hematochezia

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>485 patients,who have an average risk (asymptomatic and without colon screening in the last 5 years) or those who have a high risk for colon cancer (strong family history of colon cancer or polyps and/or personal history of colon cancer or polyps). | |
| 2<br>160 patients, with a known colorectal lesion at or greater than 1 cm. | |
| 3<br>610 patients, who are of average risk for colon cancer (asymptomatic and no colon cancer screening in the last 5 years). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. |  | 2000-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests |  | 2000-2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Polyps, Colon, Large Intestine, Cecum, Sigmoid, Rectum, Colonoscopy, Virtual Colonoscopy, CT Colonography, Computed Tomographic Colonography, Colonography