Participation and Detection Rate Diagnostic of a Colorectal Cancer Screening Program: CT Colonography vs. Flexible Sigmoidoscopy (Proteus)

• Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program [ Time Frame: three years ] [ Designated as safety issue: No ]
  
• Participation rate to FS and CT Colonography [ Time Frame: one year ] [ Designated as safety issue: No ]
  

• Number of participants with severe adverse events in both screening groups [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  
• Costs of a CRC screening based on CTC [ Time Frame: three years ] [ Designated as safety issue: No ]
  
• Type of false positive detections of Computer-aided detection for CTC in a CRC screening program [ Time Frame: three years ] [ Designated as safety issue: No ]
  

Design:

• To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy (FS), a total of 20.000 eligible individuals living in the target areas are mailed an invitation letter to participate in the trial. All invitees are asked to call the screening centre in order to receive detailed information about study protocol, the screening examinations and the bowel preparation. Responders who consent to participate in the study are randomly assigned to undergo screening with CTC or FS. All non-responders will be invited to Fecal Occult Blood test (FOBT) according to the current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
• To compare participation rate to FS and CTC, 1200 individuals living in the target areas and never screened for colorectal cancer, are randomly assigned to receive an invitation for screening with CTC or FS. Individuals of both groups will receive an invitation letter and an information leaflet, containing information about colorectal cancer, importance of screening, and advantages and possible risks of the selected test. Invitation letter for CTC contains a phone number of the screening centre. All invitees are asked to call the screening centre in order to receive information about bowel preparation. All non-responders will receive a remainder by mail after one month. Non-responders to reminder will be invited to FS according with current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.