Participation and Detection Rate Diagnostic of a Colorectal Cancer Screening Program: CT Colonography vs. Flexible Sigmoidoscopy
The trial is a multicenter randomized controlled trial (RCT) among average risk population aged 58-60 years, comparing the detection rates of advanced neoplasia (advanced adenoma and CRC) of CT colonography (CTC) and sigmoidoscopy (FS) and the participation rates within the two programs. The trial will further validate a CTC screening protocol adopting an organizational model based on telediagnosis together with involving CAD as a first for CTC interpretation. The cost-effectiveness of this protocol will also be tested in the proposed RCT.
An invitation letter to participate in a randomized screening trial comparing CTC vs. FS is mailed to a sample of 20,000 people aged 58-60 years, living in the Piedmont Region, Italy and in the Verona district, Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, recent colonoscopy, or two first-degree relatives with CRC are excluded from the study by their general practitioners. Individuals responding positively are then randomized to the intervention group (CTC) or control group (FS) and scheduled for screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests; secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC vs. FS, and the expected and perceived burden of the procedures. To compare participation rate of CTC vs. FS, 2,000 additional eligible subjects are randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders are offered FOBT as alternative screening test. In the FS arm, non-responders receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected.
The trial is ongoing and has been registered with identifier: NCT01739608
This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting.