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Open Access Study protocol

Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial

Daniele Regge1, Gabriella Iussich1, Carlo Senore2, Loredana Correale3*, Cesare Hassan4, Alberto Bert3, Stefania Montemezzi5 and Nereo Segnan2

Author Affiliations

1 Radiology Unit, Institute for Cancer Research and Treatment, FPO, Strada Provinciale 142, Candiolo 10060, Italy

2 CPO Piemonte and AO ‘City of Health and Science,’ SC Epidemiologia dei Tumori, Turin, Italy

3 im3D SpA, Turin, Italy

4 Department of Radiological Sciences Oncology and Pathology, University of Rome La Sapienza, Rome, Italy

5 Radiology Unit, Azienda Ospedaliera di Verona, Verona, Italy

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Trials 2014, 15:97  doi:10.1186/1745-6215-15-97

Published: 28 March 2014

Abstract

Background

Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening.

Methods/Design

An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the 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 versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected.

Discussion

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.

Trial registration

ClinicalTrials.gov Identifier: NCT01739608

Keywords:
Colorectal cancer; Screening; Flexible sigmoidoscopy; CT colonography; Computer-aided detection