Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The objectives of this multicenter, randomized trial is to assess the participation rate
      achievable through two different screening strategies (Computed Tomographic Colonography-CTC
      and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced
      adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for
      CTC screening will be also assessed. The trial involves 10 Italian centers located in the
      Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for
      recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family
      history or hereditary syndromes; personal history of inflammatory bowel disease; patients
      screened by colonoscopy or FOBT within 2 years; severe disease.
    

Detailed description: 
      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.
    

Intervention name(s): Invitation to screening
Intervention type(s): Other
Intervention description(s): Invitation to screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: CRC