Screening for Colorectal Cancer With FOBT, Virtual Colonoscopy and Optical Colonoscopy. A Randomized Clinical Trial in the Florence District (SAVE)
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ClinicalTrials.gov Identifier: NCT01651624 |
Recruitment Status :
Completed
First Posted : July 27, 2012
Last Update Posted : November 27, 2018
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RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting colorectal neoplasms and may be a primary test in colorectal cancer screening.
PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a primary screening test in a population-based programme.
Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer | Other: Invitation to screening | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16087 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Comparison Between Faecal Occult Blood Test (FOBT), Computed Tomographic Colonography (CTC) With Computer Aided Diagnosis (CAD) and Colonoscopy as a Primary Screening Test for Colorectal Cancer. Validation of a Teleradiology Model. Biological Banking in Subjects Recruited for Colonoscopy or CTC. |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | November 25, 2018 |
Actual Study Completion Date : | November 25, 2018 |

Arm | Intervention/treatment |
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Experimental: Computed tomographic colonography (CTC), reduced prep
Subjects invited to undergo CTC with reduced cathartic preparation
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Other: Invitation to screening |
Experimental: Computed tomographic colonography (CTC), standard prep
Subjects invited to undergo CTC with standard bowel preparation
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Other: Invitation to screening |
Active Comparator: Faecal occult blood test (FOBT)
Subjects invited to undergo FOBT
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Other: Invitation to screening |
Experimental: Colonoscopy
Subjects invited to undergo colonoscopy
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Other: Invitation to screening |
- Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy [ Time Frame: 2 years ]
- Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ]
- Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ]
- Costs of the three different screening strategies proposed [ Time Frame: 6 years ]
- Expected and perceived burden of colonoscopy and CTC [ Time Frame: 2 years ]
- Number and type of complications in all groups [ Time Frame: 2 years ]

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Ages Eligible for Study: | 55 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Never invited to previous colorectal cancer screening.
Exclusion Criteria:
- Personal history of colorectal cancer or colonic advanced adenomas.
- Inflammatory bowel disease (IBD).
- Previous five years complete colonoscopy or previous two years faecal occult blood test (FOBT).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651624
Italy | |
Cancer Prevention and Research Institute, ISPO | |
Firenze, FI, Italy, 50139 |
Principal Investigator: | Stefano Milani, MD | University of Florence | |
Study Director: | Grazia Grazzini, MD | Cancer Prevention and Research Institute, Italy |
Responsible Party: | Cancer Prevention and Research Institute, Italy |
ClinicalTrials.gov Identifier: | NCT01651624 |
Other Study ID Numbers: |
D65C09002710007 432/10 ( Other Identifier: Local Ethics Committee of Local Health Unit of Florence ) |
First Posted: | July 27, 2012 Key Record Dates |
Last Update Posted: | November 27, 2018 |
Last Verified: | November 2018 |
Colorectal Cancer Screening Fecal Occult Blood Test |
CT Colonography Virtual Colonoscopy Colonoscopy |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |