Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy (Proteus)

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Invitation to screening

Study type: Interventional

Funder types: Other

Identifiers

NCT01739608

14334-c27.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40,945 patients

Sex: All

Ages: 58 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asymptomatic individuals, at average risk for CRC, 58-60 years old.

Exclusion criteria

• Personal history of CRC or polyps
• Family history of CRC or polyps
• A terminal illness or inflammatory bowel disease
• Previous five years complete colonoscopy or a FOBT within the previous 2 years
• Patients who are unable to give informed consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40,945 participants in 2 patient groups

CT Colonography (CTC)

Experimental group

Description:

Invitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation.

Treatment:

Other: Invitation to screening

Sigmoidoscopy (FS)

Active Comparator group

Description:

Invitation to screening. Subjects who consent to participate in the study undergo to FS.

Treatment:

Other: Invitation to screening