title: Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study).
abstract: BACKGROUND
  Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening.
  
  
  METHODS
  A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC.
  
  
  CONCLUSIONS
  This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01651624.
authors.affiliation: Radiodiagnostic Section, Department of Clinical Physiopathology, University of Florence, Viale G, Pieraccini 6, 50139 Florence, Italy.
authors.forename: Lapo
authors.initials: L
authors.lastname: Sali
authors.forename: Grazia
authors.initials: G
authors.lastname: Grazzini
authors.forename: Francesca
authors.initials: F
authors.lastname: Carozzi
authors.forename: Guido
authors.initials: G
authors.lastname: Castiglione
authors.forename: Massimo
authors.initials: M
authors.lastname: Falchini
authors.forename: Beatrice
authors.initials: B
authors.lastname: Mallardi
authors.forename: Paola
authors.initials: P
authors.lastname: Mantellini
authors.forename: Leonardo
authors.initials: L
authors.lastname: Ventura
authors.forename: Daniele
authors.initials: D
authors.lastname: Regge
authors.forename: Marco
authors.initials: M
authors.lastname: Zappa
authors.forename: Mario
authors.initials: M
authors.lastname: Mascalchi
authors.forename: Stefano
authors.initials: S
authors.lastname: Milani
mesh_terms: D000236:Adenoma / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000191:economics / Q000473:pathology / Q000628:therapy; D018070:Biological Specimen Banks; D002985:Clinical Protocols; D023881:Colonography, Computed Tomographic / Q000191:economics; D003113:Colonoscopy / Q000191:economics; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000191:economics / Q000473:pathology / Q000628:therapy; D003365:Costs and Cost Analysis; D017048:Health Care Costs; D006801:Humans; D007558:Italy; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D008875:Middle Aged; D009780:Occult Blood; D010342:Patient Acceptance of Health Care; D011237:Predictive Value of Tests; D011379:Prognosis; D011857:Radiographic Image Interpretation, Computer-Assisted; D012017:Referral and Consultation; D012107:Research Design