Clinical trial · Interventional
Screening for Colorectal Cancer With FOBT, Virtual Colonoscopy and Optical Colonoscopy. A Randomized Clinical Trial in the Florence District
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Invitation to screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Computed tomographic colonography (CTC), reduced prep
- description
- Subjects invited to undergo CTC with reduced cathartic preparation
- interventionNames
- Other: Invitation to screening
- type
- EXPERIMENTAL
- label
- Computed tomographic colonography (CTC), standard prep
- description
- Subjects invited to undergo CTC with standard bowel preparation
- interventionNames
- Other: Invitation to screening
- type
- ACTIVE_COMPARATOR
- label
- Faecal occult blood test (FOBT)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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).
References
Publications (3)
- DERIVEDPuliti D, Sali L, Mascalchi M, Manneschi G, Intrieri T, Caldarella A, Mallardi B, Masala G, Gorini G, Zappa M, Mantellini P. Colorectal Cancer and Advanced Adenoma after Single CT Colonography or Biennial FIT Screening in the SAVE Randomized Controlled Trial. Radiology. 2025 Sep;316(3):e250091. doi: 10.1148/radiol.250091. PMID 41025989
- DERIVEDSali L, Ventura L, Mascalchi M, Falchini M, Mallardi B, Carozzi F, Milani S, Zappa M, Grazzini G, Mantellini P. Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1016-1023. doi: 10.1016/S2468-1253(22)00269-2. Epub 2022 Sep 16. PMID 36116454
- DERIVEDSali L, Grazzini G, Carozzi F, Castiglione G, Falchini M, Mallardi B, Mantellini P, Ventura L, Regge D, Zappa M, Mascalchi M, Milani S. Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study). Trials. 2013 Mar 15;14:74. doi: 10.1186/1745-6215-14-74. PMID 23497601