Evaluation of accuracy of computed tomographic colonography (CTC) in the diagnosis of colorectal tumor by gastroenterologists and radiologists with computer-aided detection (CAD): A multicenter study

UMIN ID: UMIN000002097

Registered date:20/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: colorectal cancer, colorectal polyp
• Date of first enrollment: 2009/08/01
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CTC and optical colonoscopy

Outcome(s)

• Primary Outcome: CTC vs. optical colonoscopy. Detection performance and accuracy of colorectal polyps (at least 6 mm in diameter) and colorectal cancer.
• Secondary Outcome: The differences of detection performance of human readings without and with CAD. Diagnostic performances between radiologists and gastroenterologists. Comparative adherence of patients to CTC and optical colonoscopy. Frequency and nature of any adverse events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Known colorectal polyps or cancers at any site at the time of enrollment. 2) Patients with inflammatory bowel disease. 3) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria). 4) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit. 5) Previous colorectal surgery. 6) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon. 7) Evidence of an increased risk in carrying out bowel preparation or CTC exams. 8) Possibility of pregnancy. 9) Optical colonoscopy or barium enema carried out within the last 3 years. 10) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial. 11) Iodine hypersensitivity. 12) Severe thyroid disease. 13) Claustrophobia. 14) Severe deafness. 15) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Related Information

• Primary Sponsor: Japanese CTC Society
• Secondary Sponsor: Showa University Northern Yokohama Hospital
• Source(s) of Monetary Support: Ajinomoto Co., Inc.,Aze, Ltd. Horii Pharmaceutical Ind., Ltd. CancerScan Co., Ltd.
• Secondary ID(s): NCT00997802