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




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Trials

, 15:97

First Online: 28 March 2014Received: 17 July 2013Accepted: 31 October 2013DOI: 10.1186-1745-6215-15-97

Cite this article as: Regge, D., Iussich, G., Senore, C. et al. Trials 2014 15: 97. doi:10.1186-1745-6215-15-97

Abstract

BackgroundColorectal 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-DesignAn 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.

DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT01739608

KeywordsColorectal cancer Screening Flexible sigmoidoscopy CT colonography Computer-aided detection AbbreviationsAAAAbdominal aortic aneurysms

CADComputer-aided detection

DR FR-CADDouble-reading first-reader computer-aided detection

C-RADSCT Colonography Reporting and Data System

CRCColorectal cancer

DICOMDigital Imaging and Communications in Medicine

FOBTFecal occult blood test

iFOBTFecal immunochemical test

gFOBTGuaiac fecal occult blood test

FSFlexible sigmoidoscopy

CTColonography

CTCRCTRandomized clinical trial

ITInformation technology

ICTInformation communications technology

QOLQuality of life.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-97 contains supplementary material, which is available to authorized users.

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Autor: Daniele Regge - Gabriella Iussich - Carlo Senore - Loredana Correale - Cesare Hassan - Alberto Bert - Stefania Montemezzi -

Fuente: https://link.springer.com/







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